The following data is part of a premarket notification filed by Precision Surgical Instrument, Inc. with the FDA for Microinfertility Needle Holder, Titanium.
| Device ID | K844821 |
| 510k Number | K844821 |
| Device Name: | MICROINFERTILITY NEEDLE HOLDER, TITANIUM |
| Classification | Instrument, Manual, Specialized Obstetric-gynecologic |
| Applicant | PRECISION SURGICAL INSTRUMENT, INC. 83 EAST WATER ST., BOX 35 Rockland, MA 02370 |
| Contact | Mi Feeney |
| Correspondent | Mi 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 |