VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS

Arthroscope

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Various Arthroscopes, Endoscopic Blades, Manual Instruments.

Pre-market Notification Details

Device IDK971253
510k NumberK971253
Device Name:VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
ClassificationArthroscope
Applicant SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover,  MA  01810
ContactElizabeth A Ryan
CorrespondentElizabeth A Ryan
SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover,  MA  01810
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-03
Decision Date1997-06-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885556606650 K971253 000
00885556606124 K971253 000
00885556561461 K971253 000
00885556561454 K971253 000
00885556561225 K971253 000
00885556561218 K971253 000
00885554014778 K971253 000
00885554005486 K971253 000
00885554003109 K971253 000
03596010122322 K971253 000
03596010122308 K971253 000
00885556606131 K971253 000
00885556606247 K971253 000
00885556606254 K971253 000
00885556606643 K971253 000
00885556606636 K971253 000
00885556606629 K971253 000
00885556606612 K971253 000
00885556606605 K971253 000
00885556606599 K971253 000
00885556606582 K971253 000
00885556606575 K971253 000
00885556606322 K971253 000
00885556606261 K971253 000
03596010122230 K971253 000

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