The following data is part of a premarket notification filed by Dacomed Corp. with the FDA for Dacomed Snap-gauge.
| Device ID | K820615 |
| 510k Number | K820615 |
| Device Name: | DACOMED SNAP-GAUGE |
| Classification | Monitor, Penile Tumescence |
| Applicant | DACOMED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-08 |
| Decision Date | 1982-04-21 |