The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Tissue Retaining Component.
| Device ID | K923679 |
| 510k Number | K923679 |
| Device Name: | ENDOPATH TISSUE RETAINING COMPONENT |
| Classification | Applicator, Ent |
| 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 | KCJ |
| CFR Regulation Number | 874.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-22 |
| Decision Date | 1992-09-09 |