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510(k) K891334

Device
ACU-CURETTE
Applicant
ACUDERM, INC.
510(k) number
K891334
Product code
FZS  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-11
Date received
1989-03-10
Regulation
878.4800
Classification name
Curette, 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#

Contact
CHARLES R YEH
Address
5370 NW 35th Ter. Ft. Lauderdale FL US 33309 33309

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FZS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932493SURGICAL CURETTEWhitney Products, Inc.1994-01-07
K902000KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELDKevtek Medical Products, Inc.1990-08-21
K892521CYMED MICROSKIN(R) DISPOSABLE IRRIGATION SLEEVECymed, Inc.1989-05-01
K891888CURRETTES - PIFFARD, WOLF, VIDAL-SCRAPERZinnanti Surgical Instruments, Inc.1989-04-12
K890366ADENOID CURETTEKinetic Medical Products1989-02-03
K875292MICRODISCECTOMY CURETTE SETT. Korossurgical Instruments Corp.1988-01-29
K871925STRAIGHT CUP CURRETTE, 1.7MMArthropedics, Inc.1987-06-01
K854888RANDALL CURETTEEuro-Med Intl.1985-12-24
K854899NOVAK CURETTEEuro-Med Intl.1985-12-24
K842701HOPPENSTEIN MICROSURGICAL SPINAL INSTRUDowns Surgical , Ltd.1984-08-02
K831367PMN VOLZ CURETTES3M Company1983-05-25
K831119LUO CURRETTES #3211Pmt, Inc.1983-05-09
K803178ANSPACH MENISECTOMY KNIFEThe Anspach Effort, Inc.1981-02-13

Legacy Summary#

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FDA Review#

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