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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Depressor, Tongue, Non-Surgical
510(k) Number K842461
Device Name TONGUE DEPRESSOR
Applicant
The Torrent Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact GARY L SWANSON
Correspondent
The Torrent Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact GARY L SWANSON
Regulation Number880.6230
Classification Product Code
FMA  
Date Received06/22/1984
Decision Date 11/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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