The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Dacomed Penile Prosthesis Sizer.
| Device ID | K870320 |
| 510k Number | K870320 |
| Device Name: | DACOMED PENILE PROSTHESIS SIZER |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Contact | Mary M Wilen |
| Correspondent | Mary M Wilen DACOMED CORP. 1701 E. 79TH ST., STE. 17 Minneapolis, MN 55425 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-28 |
| Decision Date | 1987-03-17 |