The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Procedure Ready Trays.
Device ID | K884577 |
510k Number | K884577 |
Device Name: | PROCEDURE READY TRAYS |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Contact | Jame E Williams |
Correspondent | Jame E Williams PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-01 |
Decision Date | 1989-08-01 |