The following data is part of a premarket notification filed by Bionix Development Corp. with the FDA for One/circ (circumcision Clamp).
| Device ID | K900370 |
| 510k Number | K900370 |
| Device Name: | ONE/CIRC (CIRCUMCISION CLAMP) |
| Classification | Clamp, Circumcision |
| Applicant | BIONIX DEVELOPMENT CORP. 757 WAREHOUSE RD. STE.G Toledo, OH 43615 |
| Contact | Huttner, Md |
| Correspondent | Huttner, Md BIONIX DEVELOPMENT CORP. 757 WAREHOUSE RD. STE.G Toledo, OH 43615 |
| Product Code | HFX |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-25 |
| Decision Date | 1990-04-16 |