The following data is part of a premarket notification filed by Sudormed, Inc. with the FDA for Sudormed Sweat Patch Specimen Container For Collection Of Amphetamines In Perspiration.
| Device ID | K935588 |
| 510k Number | K935588 |
| Device Name: | SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | SUDORMED, INC. 12341 NEWPORT AVE., #D-200 SANTA ANA, CA 92705 |
| Contact | JON BOOHER |
| Correspondent | JON BOOHER 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 | 1993-11-17 |
| Decision Date | 1995-07-14 |