The following data is part of a premarket notification filed by Nice-pak Products, Inc. with the FDA for Pdi Surgical Scrub/brush T150-70.
| Device ID | K833549 |
| 510k Number | K833549 |
| Device Name: | PDI SURGICAL SCRUB/BRUSH T150-70 |
| Classification | Gauze / Sponge,nonresorbable For External Use |
| Applicant | NICE-PAK PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | NAB |
| CFR Regulation Number | 878.4014 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-01 |
| Decision Date | 1983-11-28 |