The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Hi-q Hand Instruments- Urology.
| Device ID | K944201 |
| 510k Number | K944201 |
| Device Name: | HI-Q HAND INSTRUMENTS- UROLOGY |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-29 |
| Decision Date | 1994-11-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170154376 | K944201 | 000 |
| 04953170054389 | K944201 | 000 |