The following data is part of a premarket notification filed by Karlin Technology, Inc. with the FDA for Crank Frame Retractor.
| Device ID | K882071 |
| 510k Number | K882071 |
| Device Name: | CRANK FRAME RETRACTOR |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | KARLIN TECHNOLOGY, INC. 330 WASHINGTON ST. SUITE 314 Marina Del Rey, CA 90292 |
| Contact | Mark Weidhaas |
| Correspondent | Mark Weidhaas KARLIN TECHNOLOGY, INC. 330 WASHINGTON ST. SUITE 314 Marina Del Rey, CA 90292 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-17 |
| Decision Date | 1988-06-10 |