510(k) K911886
- Device
- PMT METAL LOCATOR, MODEL 3630-1
- Applicant
- PMT CORP.
- 510(k) number
- K911886
- Product code
- HPM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-08-12
- Date received
- 1991-04-29
- Regulation
- 886.4400
- Classification name
- Locator, Metal, Electronic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES COX
- Address
- 1500 Park Rd. Chanhassen MN US 55317 55317
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HPM #
Legacy Summary#
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FDA Review#
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