The following data is part of a premarket notification filed by Karlin Technology, Inc. with the FDA for Suction Retractor(tower Attach.)for Crank Fram Ret.
| Device ID | K903969 |
| 510k Number | K903969 |
| Device Name: | SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RET |
| Classification | Retractor |
| Applicant | KARLIN TECHNOLOGY, INC. 2730 MONTEREY ST, #104 Torrance, CA 90503 |
| Contact | Tom Mack |
| Correspondent | Tom Mack KARLIN TECHNOLOGY, INC. 2730 MONTEREY ST, #104 Torrance, CA 90503 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1990-09-05 |