The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Integrated Endoscopy System 1000.
| Device ID | K920800 |
| 510k Number | K920800 |
| Device Name: | INTEGRATED ENDOSCOPY SYSTEM 1000 |
| Classification | Arthroscope |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S 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 | 1992-02-21 |
| Decision Date | 1992-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304463912 | K920800 | 000 |
| 00880304410275 | K920800 | 000 |
| 00880304410190 | K920800 | 000 |
| 00880304409781 | K920800 | 000 |
| 00880304407947 | K920800 | 000 |
| 00880304407916 | K920800 | 000 |
| 00880304407893 | K920800 | 000 |
| 00880304407879 | K920800 | 000 |
| 00880304407862 | K920800 | 000 |
| 00880304407855 | K920800 | 000 |
| 00880304410381 | K920800 | 000 |
| 00880304410398 | K920800 | 000 |
| 00880304410497 | K920800 | 000 |
| 00880304410480 | K920800 | 000 |
| 00880304410466 | K920800 | 000 |
| 00880304410459 | K920800 | 000 |
| 00880304410442 | K920800 | 000 |
| 00880304410435 | K920800 | 000 |
| 00880304410428 | K920800 | 000 |
| 00880304410411 | K920800 | 000 |
| 00880304410404 | K920800 | 000 |
| 08428898895812 | K920800 | 000 |