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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNEEDLE ZAP
Classification Namedevice, needle destruction
Generic Namedevice, needle destruction
Applicant
E MED FUTURE
354 s. clay street
millersburg, OH 44654
PMA NumberP010065
Supplement NumberS002
Date Received11/12/2003
Decision Date02/05/2004
Product Code
MTV[ Registered Establishments with MTV ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT FRANTZ MEDICAL DEVELOPMENT, LTD., MENTOR, OHIO.
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