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510(k) K812691

Device
SILICONE IMPLANTS
Applicant
SUTTER BIOMEDICAL, INC.
510(k) number
K812691
Product code
MDM  
Decision
Substantially Equivalent (SESE)
Decision date
1981-11-16
Date received
1981-09-22
Regulation
878.4800
Classification name
Instrument, Manual, Surgical, General Use
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 MDM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K073664FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCERInjectimed, Inc.2008-08-08
K050575FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEMFutumeds Sdn Bhd2005-08-15
K050957EUTROCHARSpecial Devices, Inc.2005-05-18
K023173ANDREWS INTRODUCER, MODEL ASI01Andrews Surgical Innovations, Ltd.2002-12-18
K022059MICROVASIVE PULMONARY GUIDEWIREBoston Scientific Corp2002-11-13
K013040LIGHT SABER INTRODUCER NEEDLEMinrad, Inc.2001-12-07
K010184CHESS HAND SURGERY SYSTEMCanica Design, Inc.2001-06-22
K990062SAPHLIFTGenzyme Surgical Product (Genzyme Biosurgery)1999-03-30
K981579ENDOPOUCH PRO SPECIMEN RETRIEVAL BAGETHICON, Inc.1998-07-09
K943968TUNNELERDenver Biomedicals, Inc.1995-03-01
K945430DERMAVBLADE(TM)Hasting'S Biomedical Corp.1994-11-28
K941193EAST WEST INSTRUMENTSEast West Instruments, Inc.1994-11-09
K941907APEX DISPOSABLE INSTRUMENTSApex Ent., Inc.1994-08-26
K942818DEEP SUTUREAutomated Medical Products Corp.1994-08-25
K942896CLAMPS AND CLIPSSurgin Surgical Instrumentation, Inc.1994-07-19

Legacy Summary#

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FDA Review#

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