The following data is part of a premarket notification filed by Professional Medical Services with the FDA for Pms Percutaneous Puncture Needle.
Device ID | K854941 |
510k Number | K854941 |
Device Name: | PMS PERCUTANEOUS PUNCTURE NEEDLE |
Classification | Introducer, Catheter |
Applicant | PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Contact | James E Williams |
Correspondent | James E Williams PROFESSIONAL MEDICAL SERVICES P.O. BOX 250 700 WEST 200 NORTH North Salt Lake, UT 84054 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-10 |
Decision Date | 1986-04-16 |