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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K885122
Device Name NEEDLE STICK
Applicant
Poncy, Inc.
3725 Investment Ln.
Riviera Beach,  FL  33404
Applicant Contact MARK P PONCY
Correspondent
Poncy, Inc.
3725 Investment Ln.
Riviera Beach,  FL  33404
Correspondent Contact MARK P PONCY
Regulation Number880.5570
Classification Product Code
FMI  
Date Received12/09/1988
Decision Date 03/14/1989
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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