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510(k) K934494

Device
SURGITEL
Applicant
GENERAL SCIENTIFIC CORP.
510(k) number
K934494
Product code
HOH  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-25
Date received
1993-09-15
Regulation
886.4770
Classification name
Spectacle, Operating (loupe), Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
HARVEY C BAUSS
Address
77 Enterprise Dr. Ann Arbor MI US 48103 48103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HOH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K875124LOW-POWER BINOCULAR LOUPESeiler Instrument & Mfg. Co., Inc.1988-02-19
K810817EXETER OPERATING LOUPEExeter Instruments, Inc.1981-04-23

Legacy Summary#

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FDA Review#

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