The following data is part of a premarket notification filed by Physician Industries, Inc. with the FDA for General Procedure Kit.
Device ID | K960248 |
510k Number | K960248 |
Device Name: | GENERAL PROCEDURE KIT |
Classification | Syringe, Piston |
Applicant | PHYSICIAN INDUSTRIES, INC. 101 NORTH 700 WST P.O. BOX 540793 North Salt Lake, UT 84054 -0793 |
Contact | Brian Baker |
Correspondent | Brian Baker PHYSICIAN INDUSTRIES, INC. 101 NORTH 700 WST P.O. BOX 540793 North Salt Lake, UT 84054 -0793 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-16 |
Decision Date | 1996-04-12 |