The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Mammosite Cavity Evaluation Device.
| Device ID | K081179 |
| 510k Number | K081179 |
| Device Name: | MAMMOSITE CAVITY EVALUATION DEVICE |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01752 |
| Contact | Randall J Covill |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-25 |
| Decision Date | 2008-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045505018 | K081179 | 000 |