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510(k) K091462

Device
SPECTRA MEDICAL SAFETY SCAPEL
Applicant
SPECTRA, INC.
510(k) number
K091462
Product code
GDZ  
Decision
Substantially Equivalent (SESE)
Decision date
2009-12-15
Date received
2009-05-18
Regulation
878.4800
Classification name
Handle, Scalpel
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
AGUSTIN TURRIZA
Address
260 F&H Fordham Rd. Wilmington MA US 01887 01887

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GDZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890242SCALPEL HANDLEKinetic Medical Products1989-01-27
K884512BEAVER(R) HANDLEBd Becton Dickinson Vacutainer Systems Preanalytic1988-11-17
K863951P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLEPrecision Surgical Industries, Inc.1986-10-24
K863808THE S. CORDERO STYLUSS. Cordero Co.1986-10-14
K863212KEISEI HANDLES FOR SURGICAL BLADESKeisei Medical Industrial Co., Ltd.1986-09-02
K854858SCALPEL HANDLEMedelec Intl. Corp.1985-12-24
K852711SCALPEL HANDLE #3 SS 410 OR 420The Huxley Instrument Corp.1985-07-15
K852735SCALPEL HANDLE #7 SS 410 OR 420The Huxley Instrument Corp.1985-07-15
K8517507-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7Artiberia1985-06-20
K852042BRIMFIELD CANNULATED BLADE HOLDERBrimfield Scientific Instruments1985-06-11
K812876SURGICAL PAWSM-W Laboratories, Inc.1981-11-20
K812814ZEE SURGICAL INSTRUMENTSZee Medical Products Co., Inc.1981-11-06
K812070BORES* ADJUSTABLE BLADE HOLDERSanta Barbara Medco, Inc.1981-08-18
K810720I.M. SCALPEL HANDLEInstrument Makar, Inc.1981-04-03
K761035SURGICAL BLADE HANDLESParke-Davis Co.1976-12-21

Legacy Summary#

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FDA Review#

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