The following data is part of a premarket notification filed by Rudolph Beaver, Inc. with the FDA for Arthro-trac(tm).
Device ID | K883361 |
510k Number | K883361 |
Device Name: | ARTHRO-TRAC(TM) |
Classification | Arthroscope |
Applicant | RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham, MA 02154 |
Contact | Robert Zoletti |
Correspondent | Robert Zoletti RUDOLPH BEAVER, INC. 411 WAVERLEY OAKS RD. P.O. BOX 9097 Waltham, MA 02154 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-09 |
Decision Date | 1988-10-13 |