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510(k) K813337

Device
SKINNY CHIBA NEEDLE & TRAY
Applicant
AMERICAN PHARMASEAL DIV. AHSC
510(k) number
K813337
Product code
FSH  
Decision
Substantially Equivalent (SESE)
Decision date
1982-01-28
Date received
1981-11-24
Regulation
878.4800
Classification name
Tray, Surgical, Needle
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FSH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884876S 4 INSTRUMENT STANDCarl Zeiss, Inc.1988-12-15
K883578S 21 INSTRUMENT STANDCarl Zeiss, Inc.1988-09-13
K821921STAND, SURG. INSTRUMENT & DRESSINGEmerson-Sack-Warner Corp.1982-07-30
K813338BIOPSY NEEDLES & TRAYSAmerican Pharmaseal Div. Ahsc1982-01-28
K813335PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAYAmerican Pharmaseal Div. Ahsc1982-01-08
K780759MODEL 902 STANDApplied Medical Research1978-05-19
K772188FSH RIA KIT (125I)Diagnostic Products Corp.1977-12-22

Legacy Summary#

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FDA Review#

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