510(k) K831229
- Device
- SUPER SNAPS
- Applicant
- SHOFU DENTAL CORP.
- 510(k) number
- K831229
- Product code
- FHJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-05-09
- Date received
- 1983-04-15
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FHJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K902119 | SAFEBRIS STERILE CIRCUMCISION KIT | Kedumin Kits, Ltd. | 1990-11-05 |
Legacy Summary#
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FDA Review#
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