The following data is part of a premarket notification filed by Endotec, Inc. with the FDA for Carrier, Ligature (79 Gej).
| Device ID | K944465 |
| 510k Number | K944465 |
| Device Name: | CARRIER, LIGATURE (79 GEJ) |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ENDOTEC, INC. 6550A BEST FRIEND RD. Norcross, GA 30071 |
| Contact | Freddie P Andrieni |
| Correspondent | Freddie P Andrieni ENDOTEC, INC. 6550A BEST FRIEND RD. Norcross, GA 30071 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-12 |
| Decision Date | 1994-09-28 |