Atlas FDA

KESTREL NO. 695 HEATER

FDA premarket approval P820087/S002 · decided 1985-02-08

Approval details

PMA number
P820087
Supplement
S002
Trade name
KESTREL NO. 695 HEATER
Generic name
Accessories, soft lens products
Applicant
Atrion Medical Products, Inc.
Date received
1983-11-08
Decision date
1985-02-08
Days to decision
458 days
Decision code
APPR
Product code
LPN
Advisory committee
Ophthalmic
Expedited review
No
Location
Arab, AL

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510(k) clearances by this applicant

RecordFirmDate
QL LOCKING SYRINGE (K060643)Atrion Medical Products, Inc.2006-07-12
ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE (K043249)Atrion Medical Products, Inc.2005-05-25
ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM (K041158)Atrion Medical Products, Inc.2004-06-16
ATRION MEDICAL QL INFLATION DEVICE (K032840)Atrion Medical Products, Inc.2004-03-03
ATRION MEDICAL QL FLUID DISPENSING SYRINGE (K020333)Atrion Medical Products, Inc.2002-04-25
ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET (K973633)Atrion Medical Products, Inc.1998-01-16
ATRION MEDICAL COATED LACRIMAL INTUBATION SET (K973872)Atrion Medical Products, Inc.1998-01-08
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (K972964)Atrion Medical Products, Inc.1997-10-10