The following data is part of a premarket notification filed by Imagyn Medical Technologies, Inc. with the FDA for Impower External Vacuum System.
| Device ID | K980291 |
| 510k Number | K980291 |
| Device Name: | IMPOWER EXTERNAL VACUUM SYSTEM |
| Classification | Device, External Penile Rigidity |
| Applicant | IMAGYN MEDICAL TECHNOLOGIES, INC. 27651 LA PAZ RD. Laguna Niguel, CA 92677 -3917 |
| Contact | Ronald H Bergeson |
| Correspondent | Ronald H Bergeson IMAGYN MEDICAL TECHNOLOGIES, INC. 27651 LA PAZ RD. Laguna Niguel, CA 92677 -3917 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-26 |
| Decision Date | 1998-03-11 |
| Summary: | summary |