The following data is part of a premarket notification filed by Novadien Healthcare with the FDA for Circumplast Circumcision Device.
| Device ID | K151095 |
| 510k Number | K151095 |
| Device Name: | Circumplast Circumcision Device |
| Classification | Clamp, Circumcision |
| Applicant | Novadien Healthcare PO Box 7070 Mount Lewis, AU Nsw 2190 |
| Contact | Milad Melhem |
| Correspondent | Diane Sudduth Emergo Group 816 Congress Avenue Suite 1400 Austin, TX 78701 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-23 |
| Decision Date | 2015-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09351108000074 | K151095 | 000 |
| 09351108000067 | K151095 | 000 |
| 09351108000050 | K151095 | 000 |
| 09351108000043 | K151095 | 000 |
| 09351108000036 | K151095 | 000 |
| 09351108000029 | K151095 | 000 |
| 09351108000012 | K151095 | 000 |
| 09351108000005 | K151095 | 000 |