510(k) K903878
- Device
- MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT
- Applicant
- MENTOR O & O, INC.
- 510(k) number
- K903878
- Product code
- HQQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-11-05
- Date received
- 1990-08-22
- Regulation
- 886.4100
- Classification name
- Apparatus, Cautery, Radiofrequency, Battery-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD L FOLLETT
- Address
- 3000 Longwater Dr. Norwell MA US 02061 02061
FDA Registration Numbers#
- 1319639
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQQ #
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