The following data is part of a premarket notification filed by Technology Management & Marketing, Inc. with the FDA for Gonostat Male Specimen Collection & Transport.
| Device ID | K872326 |
| 510k Number | K872326 |
| Device Name: | GONOSTAT MALE SPECIMEN COLLECTION & TRANSPORT |
| Classification | System, Transport, Aerobic |
| Applicant | TECHNOLOGY MANAGEMENT & MARKETING, INC. 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Contact | A Marcouiller |
| Correspondent | A Marcouiller TECHNOLOGY MANAGEMENT & MARKETING, INC. 333 WEST WACKER DR. SUITE 1900 Chicago, IL 60606 |
| Product Code | JTW |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-17 |
| Decision Date | 1987-08-11 |