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510(k) K892542

Device
RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU
Applicant
ZINNANTI SURGICAL INSTRUMENTS, INC.
510(k) number
K892542
Product code
FFN  
Decision
Substantially Equivalent (SESE)
Decision date
1989-05-09
Date received
1989-04-11
Regulation
876.4730
Classification name
Clamp, Non-electrical
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ANNA STRAIGHT
Address
21540-B Prairie St. Chatsworth CA US 91311 91311

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FFN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K932408AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETSBaxter Healthcare Corp1993-09-28
K892550BEST COLON CLAMPZinnanti Surgical Instruments, Inc.1989-05-09
K772405TUBING CLAMPFred Sammons, Inc.1978-01-26
K771421CATHETEO CLAMPQuinton, Inc.1977-10-25

Legacy Summary#

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FDA Review#

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