ARTHRO-TRAC(TM)

Arthroscope

RUDOLPH BEAVER, INC.

The following data is part of a premarket notification filed by Rudolph Beaver, Inc. with the FDA for Arthro-trac(tm).

Pre-market Notification Details

Device IDK883361
510k NumberK883361
Device Name:ARTHRO-TRAC(TM)
ClassificationArthroscope
Applicant RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham,  MA  02154
ContactRobert Zoletti
CorrespondentRobert Zoletti
RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham,  MA  02154
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-09
Decision Date1988-10-13

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.