The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Endopouch Pro Specimen Retrieval Bag.
| Device ID | K981579 |
| 510k Number | K981579 |
| Device Name: | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
| Contact | Gregory R Jones |
| Correspondent | Gregory R Jones ETHICON, INC. P.O BOX 151, ROUTE 22 WEST Somerville, NJ 08876 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-04 |
| Decision Date | 1998-07-09 |
| Summary: | summary |