The following data is part of a premarket notification filed by Sudormed, Inc. with the FDA for Sudormed Sweat Patch Speciment Container (phencyclidine).
Device ID | K936240 |
510k Number | K936240 |
Device Name: | SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) |
Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
Applicant | SUDORMED, INC. 12341 NEWPORT AVE., #D-200 SANTA ANA, CA 92705 |
Contact | JON BOOHER, PH.D |
Correspondent | JON BOOHER, PH.D SUDORMED, INC. 12341 NEWPORT AVE., #D-200 SANTA ANA, CA 92705 |
Product Code | JKA |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-30 |
Decision Date | 1996-03-19 |