The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Arthroscopy System.
| Device ID | K951354 |
| 510k Number | K951354 |
| Device Name: | OLYMPUS ARTHROSCOPY SYSTEM |
| Classification | Arthroscope |
| Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Subhash R Patel |
| Correspondent | Subhash R Patel OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-24 |
| Decision Date | 1995-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847399005830 | K951354 | 000 |
| 04042761010542 | K951354 | 000 |
| 04042761010559 | K951354 | 000 |
| 04042761010627 | K951354 | 000 |
| 04042761010634 | K951354 | 000 |
| 04042761010641 | K951354 | 000 |
| 04042761010658 | K951354 | 000 |
| 04042761010955 | K951354 | 000 |
| 04042761010962 | K951354 | 000 |
| 04042761010979 | K951354 | 000 |
| 04042761010986 | K951354 | 000 |
| 00847399005823 | K951354 | 000 |
| 04042761010535 | K951354 | 000 |