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510(k) K863359

Device
BOUFFANT-STYLE SURGICAL CAP
Applicant
KIMBERLY-CLARK CORP.
510(k) number
K863359
Product code
FYF  
Decision
Substantially Equivalent (SESE)
Decision date
1986-09-29
Date received
1986-09-02
Regulation
878.4040
Classification name
Cap, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CYNTHIA SMITH
Address
1400 Holcomb Bridge Rd. Roswell GA US 30076 30076

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FYF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972227SHOE COVERAmerican Seal Co.1997-09-09
K955833NIOMED SURGICAL CAPSAmerasia Corp.1996-03-15
K954556SURGICAL CAPThai Disposable Products Co., Ltd.1996-03-12
K954454NIOMED SURGICAL HOODAmerasia Corp.1996-01-23
K954455NIOMED BOUFFANT CAPSAmerasia Corp.1996-01-23
K953878BOUFFANT CAPAmerican Threshold Industries, Inc.1996-01-05
K953879SURGEON'S CAPAmerican Threshold Industries, Inc.1996-01-05
K913700DISPOSABLE BOUFFANT CAPGem Nonwovews, Inc.1991-10-04
K882346INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARDNordbye, Milchman, Barlage1988-06-30
K882283BOUFFANT CAPA Plus International, Inc.1988-06-23
K882284SURGEONS CAPA Plus International, Inc.1988-06-23
K880481CARETEX SURGEON'S CAPSJames River Corp.1988-02-24
K875261KIMBERLY-CLARK FULL COVERAGE HOODKimberly-Clark Corp.1988-01-22
K874066SURGICAL CAPSInterpro Intl., Inc.1987-11-04
K873830TECNOL SURGEON'S CAPTecnol New Jersey Wound Care, Inc.1987-10-23

Legacy Summary#

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FDA Review#

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