The following data is part of a premarket notification filed by Medi-plast Intl., Inc. with the FDA for Sterile Pan Set.
| Device ID | K842136 | 
| 510k Number | K842136 | 
| Device Name: | STERILE PAN SET | 
| Classification | Wrap, Sterilization | 
| Applicant | MEDI-PLAST INTL., 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 | 1984-05-30 | 
| Decision Date | 1984-07-06 |