The following data is part of a premarket notification filed by Dynatech Medical Products with the FDA for Impervious Isolation Shoe Covers.
Device ID | K923187 |
510k Number | K923187 |
Device Name: | IMPERVIOUS ISOLATION SHOE COVERS |
Classification | Shoes, Operating-room |
Applicant | DYNATECH MEDICAL PRODUCTS 605 WHITE HILLS DR. Rockwall, TX 75087 |
Contact | Mitchell Davis |
Correspondent | Mitchell Davis DYNATECH MEDICAL PRODUCTS 605 WHITE HILLS DR. Rockwall, TX 75087 |
Product Code | FXW |
CFR Regulation Number | 878.4040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-30 |
Decision Date | 1993-01-29 |