The following data is part of a premarket notification filed by Uromed Corp. with the FDA for Modification To Cavermap Surgical Aid.
| Device ID | K010098 |
| 510k Number | K010098 |
| Device Name: | MODIFICATION TO CAVERMAP SURGICAL AID |
| Classification | Probe And Director, Gastro-urology |
| Applicant | UROMED CORP. 1400 PROVIDENCE HWY. Norwood, MA 02062 |
| Contact | Frederick Tobia |
| Correspondent | Frederick Tobia UROMED CORP. 1400 PROVIDENCE HWY. Norwood, MA 02062 |
| Product Code | FGM |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-11 |
| Decision Date | 2001-02-01 |