SAFEBRIS STERILE CIRCUMCISION KIT
FDA 510(k) clearance K902119 · decided 1990-11-05
Clearance details
- K-number
- K902119
- Device name
- SAFEBRIS STERILE CIRCUMCISION KIT
- Applicant
- Kedumin Kits, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-05-09
- Decision date
- 1990-11-05
- Days to decision
- 180 days
- Clearance type
- Traditional
- Product code
- FHJ
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Rehovot, Israel, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SUPER SNAPS (K831229) | Shofu Dental Corp. | 1983-05-09 |
Recalls involving this device
No recalls on record reference this clearance.