The following data is part of a premarket notification filed by Nice-pak Products, Inc. with the FDA for Pdi Surgical Scrub Sponge-brush-t15070.
| Device ID | K810337 |
| 510k Number | K810337 |
| Device Name: | PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 |
| Classification | Brush, Scrub, Operating-room |
| Applicant | NICE-PAK PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-09 |
| Decision Date | 1981-02-26 |