510(k) K911272
- Device
- ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705
- Applicant
- EDWARD WECK, INC.
- 510(k) number
- K911272
- Product code
- FHG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-07-02
- Date received
- 1991-03-22
- Regulation
- 884.4530
- Classification name
- Bell, Circumcision
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GLENN M MATTEI
- Address
- P.O. Box 12600 Weck Dr. Research Triangle Pa NC US 27709 27709
FDA Registration Numbers#
- 1836161
- 9612278
- 3018071447
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FHG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K770873 | CIRCUMCISION KIT | American Hospital Supply Corp. | 1977-07-11 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases