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510(k) K904536

Device
JAIN GRAFT ASSIST
Applicant
JAIN SURGICAL EQUIPMENT, INC.
510(k) number
K904536
Product code
GCZ  
Decision
Substantially Equivalent (SESE)
Decision date
1990-11-29
Date received
1990-10-04
Regulation
878.4800
Classification name
Retainer, Surgical
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
MELISA ROOT
Address
7829 Sprinkle Rd. Kalamazoo MI US 49001 49001

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GCZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K893870ADAMS BREAST IMPLANT PROTECTORAdept-Med Intl., Inc.1989-07-14
K870809MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206Adept-Med Intl., Inc.1987-03-19
K802806VISECERA RETAINERAdept-Med Intl., Inc.1981-01-23
K801610CHILDREN'S HOSPITAL PEDIATRIC RETRACTOREdward Weck, Inc.1980-08-04

Legacy Summary#

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FDA Review#

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