The following data is part of a premarket notification filed by O.r. Concepts, Inc. with the FDA for Cherry Sponge.
| Device ID | K913500 |
| 510k Number | K913500 |
| Device Name: | CHERRY SPONGE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | O.R. CONCEPTS, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz O.R. CONCEPTS, INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-07 |
| Decision Date | 1991-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942424627 | K913500 | 000 |
| 10889942262632 | K913500 | 000 |
| 10887761000015 | K913500 | 000 |
| 10887761000008 | K913500 | 000 |
| 00840113213993 | K913500 | 000 |
| 00840113213986 | K913500 | 000 |