The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Memory Bag.
| Device ID | K013872 |
| 510k Number | K013872 |
| Device Name: | RUSCH MEMORY BAG |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
| Contact | Rick Lykins |
| Correspondent | Rick Lykins RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-21 |
| Decision Date | 2002-02-12 |
| Summary: | summary |