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510(k) K812011

Device
BLADE GAUGE
Applicant
KOI, INC.
510(k) number
K812011
Product code
HOE  
Decision
Substantially Equivalent (SESE)
Decision date
1981-07-28
Date received
1981-07-17
Regulation
886.4350
Classification name
Caliper, Ophthalmic
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HOE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881094KOI(TM) BLADE GAUGE, MODEL KOI-132CooperVision, Inc.1988-04-01
K813315CALIPER-OPTHALMICDesign Research Assoc., Inc.1982-03-01
K820050KREMER BLADE GAUGEAccutome, Inc.1982-02-24
K801937BLEPHAROMETERAztec Medical Products, Inc.1980-09-16
K792383KELMAN DIPSTICKV. Mueller O.V. Baxter Healthcare Corp.1979-12-11
K781715RULER, WECK SCOTTEdward Weck, Inc.1978-12-04

Legacy Summary#

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FDA Review#

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