The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Disposable Specimen Bag W/cannula And Introducer.
| Device ID | K911262 |
| 510k Number | K911262 |
| Device Name: | DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER |
| Classification | Cannula, Surgical, General & Plastic Surgery |
| Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | John D Paulson |
| Correspondent | John D Paulson ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | GEA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-22 |
| Decision Date | 1991-06-20 |