The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Arthtotek Precision Hand Instrumentation.
| Device ID | K933070 |
| 510k Number | K933070 |
| Device Name: | ARTHTOTEK PRECISION HAND INSTRUMENTATION |
| Classification | Arthroscope |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia Beres |
| Correspondent | Patricia Beres BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-22 |
| Decision Date | 1994-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304402003 | K933070 | 000 |
| 00887868567469 | K933070 | 000 |