The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Hem-o-lok -- Modification.
| Device ID | K922186 |
| 510k Number | K922186 |
| Device Name: | HEM-O-LOK -- MODIFICATION |
| Classification | Staple, Implantable |
| Applicant | LINVATEC CORP. P.O. BOX 12600 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Glenn M Mattei |
| Correspondent | Glenn M Mattei LINVATEC CORP. P.O. BOX 12600 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-27 |
| Decision Date | 1992-08-06 |