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510(k) K925526

Device
MANIPLER DISPOSABLE SKIN STAPLER
Applicant
MATSUTANI SEISAKUSHO CO. LTD.
510(k) number
K925526
Product code
GDT  
Decision
Substantially Equivalent (SESE)
Decision date
1993-06-24
Date received
1992-11-02
Regulation
878.4760
Classification name
Staple, Removable (skin)
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
BRENDA M KELLY
Address
C/O The Lahr Consulting Group One Lethbridge Plz. Mahwah NJ US 07430 07430

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963234STAPLE REMOVAL KITContinental Medical Laboratories, Inc.1996-10-21
K943719VISISTAT STAPLERPilling Weck, Inc.1994-08-24
K915430SKIN STAPLE REMOVER KITCypress Medical Products, Ltd.1992-02-28
K911204QUALTEX SKIN STAPLE EXTRACTORDeroyal Industries, Inc.1991-05-08
K910586AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER*United States Surgical, A Division of Tyco Healthc1991-03-07
K900486APPOSE UNITY STERILE DISPOSABLE SKIN STAPLERDavis & Geck, Inc.1990-04-20
K861711SKIN STAPLE REMOVER WITH SPONGE STERILE DISPOSABLEBusse Hospital Disposables, Inc.1986-05-16
K851974V. MUELLER VITAL SKIN STAPLERAmerican V. Mueller1985-06-11
K844838SKIN STAT II SKIN STAPLING MEDICAL DEVICEEdward Weck, Inc.1985-01-23
K844837VISISTAT SKIN STAPLING DEVICEEdward Weck, Inc.1985-01-23
K833085STAPLE REMOVER SR300PProsper, Inc.1984-12-14
K833357VYDAX 525-550 & 5100 FLUOROTELOMERETHICON, Inc.1983-12-12
K832709SKIN STAPLING DEVICE SC2000Prosper, Inc.1983-09-26
K822365CENTURION SKIN STAPLE REMOVERTri-State1982-08-27
K821024DISP. SKIN STAPLER REMOVALBLE SKINSTAPLEHowmedica Corp.1982-05-14

Legacy Summary#

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FDA Review#

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