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SabreLine and SabreGuard Laser Fibers

Coloplast Corp.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Coloplast Corp.
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

0
Cited in this 510(k)

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K182831
Device name
SabreLine and SabreGuard Laser Fibers
Company
Coloplast Corp.
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2018-10-09
Decision date
2018-12-10
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Predicate devices

0

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Cited as predicate

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