The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Deroyal Surgical's Endoscopic Specimen Retrieval Pouch.
| Device ID | K942879 |
| 510k Number | K942879 |
| Device Name: | DEROYAL SURGICAL'S ENDOSCOPIC SPECIMEN RETRIEVAL POUCH |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LANE Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LANE Powell, TN 37849 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-17 |
| Decision Date | 1994-07-19 |