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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vibrator, Therapeutic
510(k) Number K914829
Device Name FO92 SEATING MASSAGER
Applicant
FAIRFORM MFG., CO., LTD.
5/F SHING KING INDL. BLDG.
206-208 CHOI HUNG RD.
SAN PO KONG, KOWLOON,  HK
Applicant Contact S. P WONG
Correspondent
FAIRFORM MFG., CO., LTD.
5/F SHING KING INDL. BLDG.
206-208 CHOI HUNG RD.
SAN PO KONG, KOWLOON,  HK
Correspondent Contact S. P WONG
Regulation Number890.5975
Classification Product Code
IRO  
Date Received10/25/1991
Decision Date 12/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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