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510(k) K942636

Device
PSB PREPERITONEAL STRUCTURE BALLOON
Applicant
ORIGIN MEDSYSTEMS, INC.
510(k) number
K942636
Product code
HOG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-07-01
Date received
1994-06-03
Regulation
886.4070
Classification name
Burr, Corneal, Battery-powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JILL SCHWEIGER
Address
135 Constitution Dr. Menlo Park CA US 94025 94025

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HOG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K962989AMOILS EPITHELIAL SCRUBBERS. Percy Amoils1997-01-09
K960261PALLIKARIS BRUSHAlcon Laboratories, Inc.1996-03-11
K950520BURR, CORNEAL, BATTERY-POWEREDAaron Medical Industries1995-05-02
K883785GY-RO SAFEGy-Ro Industry, Inc.1989-01-05
K834354OPHTEC RUST RING REMOVERJedmed Instrument Co.1984-03-19

Legacy Summary#

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FDA Review#

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