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510(k) K883578

Device
S 21 INSTRUMENT STAND
Applicant
CARL ZEISS, INC.
510(k) number
K883578
Product code
FSH  
Decision
Substantially Equivalent (SESE)
Decision date
1988-09-13
Date received
1988-08-22
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#

Contact
VAN CADER
Address
One Zeiss Dr. Thornwood NY US 10594 10594

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
K821921STAND, SURG. INSTRUMENT & DRESSINGEmerson-Sack-Warner Corp.1982-07-30
K813337SKINNY CHIBA NEEDLE & TRAYAmerican Pharmaseal Div. Ahsc1982-01-28
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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