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 |