KESTREL NO. 695 HEATER

FDA Premarket Approval P820087 S002

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.

Pre-market Approval Supplement Details

DeviceKESTREL NO. 695 HEATER
Generic NameAccessories, Soft Lens Products
ApplicantATRION MEDICAL PRODUCTS, INC.
Date Received1983-11-08
Decision Date1985-02-08
PMAP820087
SupplementS002
Product CodeLPN 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address ATRION MEDICAL PRODUCTS, INC. 1426 Curt Francis Rd. arab, AL 35016

Supplemental Filings

Supplement NumberDateSupplement Type
P820087Original Filing
S011 1987-12-22 Normal 180 Day Track
S010 1987-07-30 Normal 180 Day Track
S009 1987-07-13 Normal 180 Day Track
S008 1987-05-04 Normal 180 Day Track
S007 1987-03-10 Normal 180 Day Track
S006 1986-03-04
S005 1986-03-04
S004 1985-04-16
S003 1985-04-16
S002 1983-11-08
S001 1983-11-08

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