The following data is part of a premarket notification filed by F.m. Wiest Usa, Inc. with the FDA for Space(tm) 7500.
| Device ID | K912071 |
| 510k Number | K912071 |
| Device Name: | SPACE(TM) 7500 |
| Classification | Device, Erectile Dysfunction |
| Applicant | F.M. WIEST USA, INC. 690 KINDERKAMACK RD., 1ST FL. P.O. BOX 637 Oradell, NJ 07649 |
| Contact | George R Batchelor |
| Correspondent | George R Batchelor F.M. WIEST USA, INC. 690 KINDERKAMACK RD., 1ST FL. P.O. BOX 637 Oradell, NJ 07649 |
| Product Code | LST |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-10 |
| Decision Date | 1991-07-09 |