The following data is part of a premarket notification filed by Impoaid, Inc. with the FDA for Impoaid.
Device ID | K000730 |
510k Number | K000730 |
Device Name: | IMPOAID |
Classification | Device, External Penile Rigidity |
Applicant | IMPOAID, INC. P.O. BOX 560 Stillwater, MN 55082 |
Contact | Elain Duncan |
Correspondent | Elain Duncan IMPOAID, INC. P.O. BOX 560 Stillwater, MN 55082 |
Product Code | LKY |
CFR Regulation Number | 876.5020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-06 |
Decision Date | 2000-10-19 |