The following data is part of a premarket notification filed by Pro-lab, Inc. with the FDA for Dr. Gould Hand Pack Sustom Steril.
| Device ID | K842405 |
| 510k Number | K842405 |
| Device Name: | DR. GOULD HAND PACK SUSTOM STERIL |
| Classification | Wrap, Sterilization |
| Applicant | PRO-LAB, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-19 |
| Decision Date | 1984-08-15 |