510(k) K902119
- Device
- SAFEBRIS STERILE CIRCUMCISION KIT
- Applicant
- KEDUMIN KITS, LTD.
- 510(k) number
- K902119
- Product code
- FHJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-11-05
- Date received
- 1990-05-09
- Regulation
- 884.4530
- Classification name
- Shield, Circumcision
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ORBACH, PH.D.
- Address
- P.O. Box 2273 Rehovot, Israel IL
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FHJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831229 | SUPER SNAPS | Shofu Dental Corp. | 1983-05-09 |
Legacy Summary#
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FDA Review#
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