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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Extremity, Inflatable, External
510(k) Number K853600
Device Name INFLATABLE AIR SPLINTS
Applicant
Hospitak, Inc.
1144 Route 109
Lindenhurst,  NY  11757
Applicant Contact WILLIAM J LACEY
Correspondent
Hospitak, Inc.
1144 Route 109
Lindenhurst,  NY  11757
Correspondent Contact WILLIAM J LACEY
Regulation Number878.3900
Classification Product Code
FZF  
Date Received08/27/1985
Decision Date 09/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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