The following data is part of a premarket notification filed by Professional Medical Products, Inc. with the FDA for Various Kits And Trays.
Device ID | K920292 |
510k Number | K920292 |
Device Name: | VARIOUS KITS AND TRAYS |
Classification | General Surgery Tray |
Applicant | PROFESSIONAL MEDICAL PRODUCTS, INC. 1909 N.E. 25TH AVE. Ocala, FL 32670 |
Contact | R. L Cutright |
Correspondent | R. L Cutright PROFESSIONAL MEDICAL PRODUCTS, INC. 1909 N.E. 25TH AVE. Ocala, FL 32670 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-22 |
Decision Date | 1994-01-26 |