The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Hand-held Retractor, Dissector & Dissector.
| Device ID | K955120 |
| 510k Number | K955120 |
| Device Name: | HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR |
| Classification | Endoscope, Rigid |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Melissa Walker |
| Correspondent | Melissa Walker ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GCM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-09 |
| Decision Date | 1996-01-26 |