The following data is part of a premarket notification filed by Medtek Development Corp. with the FDA for Poly-med Disp. Pers. Prot. Gown Apron & Shoecovers.
| Device ID | K925077 |
| 510k Number | K925077 |
| Device Name: | POLY-MED DISP. PERS. PROT. GOWN APRON & SHOECOVERS |
| Classification | Gown, Isolation, Surgical |
| Applicant | MEDTEK DEVELOPMENT CORP. 1917 EAST TAYLOR ST. Bloomington, IL 61701 |
| Contact | William B Smith |
| Correspondent | William B Smith MEDTEK DEVELOPMENT CORP. 1917 EAST TAYLOR ST. Bloomington, IL 61701 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-07 |
| Decision Date | 1993-08-16 |