The following data is part of a premarket notification filed by Professional Medical Products, Inc. with the FDA for Patient Preoperative Prep Tray, Single Use.
Device ID | K930270 |
510k Number | K930270 |
Device Name: | PATIENT PREOPERATIVE PREP TRAY, SINGLE USE |
Classification | General Surgery Tray |
Applicant | PROFESSIONAL MEDICAL PRODUCTS, INC. 1909 N.E. 25TH AVE. Ocala, FL 32670 |
Contact | Lee Cutright |
Correspondent | Lee Cutright PROFESSIONAL MEDICAL PRODUCTS, INC. 1909 N.E. 25TH AVE. Ocala, FL 32670 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-19 |
Decision Date | 1994-02-17 |