The following data is part of a premarket notification filed by Micrins Surgical, Inc. with the FDA for Micrins Needle Holder.
| Device ID | K872989 |
| 510k Number | K872989 |
| Device Name: | MICRINS NEEDLE HOLDER |
| Classification | Holder, Needle; Orthopedic |
| Applicant | MICRINS SURGICAL, INC. 325 WEST HURON, SUITE 411 Chicago, IL 60610 |
| Contact | Bernhard Teitz |
| Correspondent | Bernhard Teitz MICRINS SURGICAL, INC. 325 WEST HURON, SUITE 411 Chicago, IL 60610 |
| Product Code | HXK |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-31 |
| Decision Date | 1987-08-21 |