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510(k) K944700

Device
ARCTIC PREMIER SERIES
Applicant
SUNGOLD EYEWEAR, INC.
510(k) number
K944700
Product code
HOY  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-22
Date received
1994-09-23
Regulation
886.4750
Classification name
Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL B JOHNSON
Address
5866 S. 194th St. Kent WA US 98032 98032

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HOY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K132042AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPANDX6d, Ltd.2014-04-28
K050856LCG (LIQUIDE CRYSTAL GLASSES) SYSTEMOphthocare , Ltd.2005-05-31
K971465NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYSNational Healthcare Mfg. Corp.1997-06-04
K944857GOGGLE SAFEGUARDSellstrom Mfg. Co.1994-12-15
K945351SHIELD, EYE, OPHTHALMICTaiwan Eva Industrial Co., Inc.1994-12-13
K945346MAKROLON 2405 GOGGLES (LIGHT AND DARK)Universal Massage & Tanning, Inc.1994-11-22
K942407AMCON SLIP IN MYDRIATIC SUNGLASSESAmcon Laboratories, Inc.1994-06-06
K941829SUN FILTERS/SHIELDSKlinger Eye Shields, Inc.1994-05-17
K930347SHAIDS PROTECTIVE GLASSESDepuy, Inc.1994-04-29
K940213UNIVERSAL CUSHIONED METAL EYE SHIELDP.J. Products, Inc.1994-03-24
K940275UNIVERSAL CUSHIONED POLYCARBONAT EYE SHIELDP.J. Products, Inc.1994-03-24
K930840POST-MYDS(TM)Aukland Medical Plastics, Inc.1994-03-01
K940095FOX EYE ALUMINUM SHIELD, OPHTHALMICP.J. Products, Inc.1994-03-01
K931254GOGGLE SAFEGUARDSellstrom Mfg. Co.1993-11-12
K934085MODIFICATION OF SURGICAL EYESHIELD MASKAmerican Threshold Industries, Inc.1993-11-12

Legacy Summary#

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FDA Review#

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