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510(k) K781539

Device
ISO-CARE KIT
Applicant
NICE-PAK PRODUCTS, INC.
510(k) number
K781539
Product code
HMP  
Decision
Substantially Equivalent (SESE)
Decision date
1978-11-03
Date received
1978-09-08
Regulation
878.4440
Classification name
Pad, Eye
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HMP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K940333EYE PADCertified Safety Mfg., Inc.1994-03-07
K921349STERILE,DISPOSABLE EYE DRESSINGDeroyal Industries, Inc.1992-05-29
K904896EYE PADUlti-Med Intl., Inc.1990-12-05
K883822FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309Consolidated Industries of Greater Syracuse, Inc.1988-11-22
K874411DONALDSON NATURAL EYEPATCH 'PATIENT PAK'Keeler Instruments, Inc.1988-01-27
K864810LIDSPLINTPrecision Therapeutics, Inc.1987-01-20
K861456SHEETS LYOPHILIZED COLLAGEN HEYEDRATORPantheon Products, Inc.1986-07-25
K860979DONALDSON NATURAL EYEPATCHKeeler Instruments, Inc.1986-04-04
K851906SURGICAL EYE PACKXanmed Corp.1985-05-21
K850099VISOPROTECT: OCCULAR SHIELDRockway Enterprises, Inc.1985-03-20
K850005VISOPROTECT OCCULAR SHIELDM.S.G. Health Systems, Inc.1985-03-20
K843197VISITEC EYE SHIELDVisitec Co.1984-10-05
K803145CONPHAR EYE PROTECTORConphar, Inc.1981-02-05
K802799EYE PADSSecol Co.1980-12-17
K801995EYE PADS CAT.#581-599Pollak (Intl.), Ltd.1980-09-09

Legacy Summary#

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FDA Review#

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