KESTREL NO. 695 HEATER

FDA Premarket Approval P820087 S011

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 Received1987-12-22
Decision Date1988-06-17
PMAP820087
SupplementS011
Product CodeLPN 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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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