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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Locator, Metal, Electronic
510(k) Number K911886
FOIA Releasable 510(k) K911886
Device Name PMT METAL LOCATOR, MODEL 3630-1
Applicant
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Applicant Contact JAMES COX
Correspondent
Pmt Corp.
1500 Park Rd.
Chanhassen,  MN  55317
Correspondent Contact JAMES COX
Regulation Number886.4400
Classification Product Code
HPM  
Date Received04/29/1991
Decision Date 08/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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