The following data is part of a premarket notification filed by Precision Surgical Instrument, Inc. with the FDA for Microinfertility Forceps, Titanium.
| Device ID | K844823 |
| 510k Number | K844823 |
| Device Name: | MICROINFERTILITY FORCEPS, TITANIUM |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | PRECISION SURGICAL INSTRUMENT, INC. 83 EAST WATER ST., BOX 35 Rockland, MA 02370 |
| Contact | Kathleen M Feeney |
| Correspondent | Kathleen M Feeney PRECISION SURGICAL INSTRUMENT, INC. 83 EAST WATER ST., BOX 35 Rockland, MA 02370 |
| Product Code | KNA |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-10 |
| Decision Date | 1985-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841019118313 | K844823 | 000 |
| 00841019115398 | K844823 | 000 |
| 00841019115107 | K844823 | 000 |
| 00841019114841 | K844823 | 000 |
| 00841019114506 | K844823 | 000 |
| 00841019114490 | K844823 | 000 |
| 00841019114483 | K844823 | 000 |
| 00841019120989 | K844823 | 000 |
| 00841019121009 | K844823 | 000 |
| 00841019120996 | K844823 | 000 |
| 00841019121023 | K844823 | 000 |
| 00841019115497 | K844823 | 000 |
| 00841019115985 | K844823 | 000 |
| 00841019118306 | K844823 | 000 |
| 00841019117729 | K844823 | 000 |
| 00841019117668 | K844823 | 000 |
| 00841019116869 | K844823 | 000 |
| 00841019116852 | K844823 | 000 |
| 00841019116593 | K844823 | 000 |
| 00841019116586 | K844823 | 000 |
| 00841019116555 | K844823 | 000 |
| 00841019116548 | K844823 | 000 |
| 00841019115992 | K844823 | 000 |
| 00841019121801 | K844823 | 000 |