The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Equipment Covers.
Device ID | K961699 |
510k Number | K961699 |
Device Name: | EQUIPMENT COVERS |
Classification | Cover, Barrier, Protective |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Janet Johnson |
Correspondent | Janet Johnson UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | MMP |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-02 |
Decision Date | 1996-08-23 |
Summary: | summary |