510(k) K881001
- Device
- MENTOR WET-FIELD*II COAGULATOR
- Applicant
- MENTOR O & O, INC.
- 510(k) number
- K881001
- Product code
- HQQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-05-13
- Date received
- 1988-03-09
- 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
- MARK TOMA
- 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#
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FDA Review#
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