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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.
 
DeviceKESTREL NO. 695 HEATER
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAtrion Medical Products, Inc.
1426 Curt Francis Rd.
Arab, AL 35016
PMA NumberP820087
Supplement NumberS011
Date Received12/22/1987
Decision Date06/17/1988
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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