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510(k) K993544

Device
SPACE-OR RETRACTOR
Applicant
ADVANCED SURGICAL CONCEPTS (ASC)
510(k) number
K993544
Product code
FFO  
Decision
Substantially Equivalent (SESE)
Decision date
1999-12-22
Date received
1999-10-19
Regulation
876.4730
Classification name
Retractor, Self-retaining
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MARY MCNAMARA CULLINANE
Address
49 Plain St. North Attleboro MA US 02760 02760

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FFO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K870897KODNER ANAL PERIONEAL RETRACTORSur-Med Instruments, Inc.1987-06-04
K860368URDYN 5000 (UROFLOWMETER)Dantec Electronics, Inc.1986-04-23
K853119URODYN 1000Dantec Electronics, Inc.1985-10-04
K852083THE KENDALL URINARY OUTPUT MONITORThe Kendal Co.1985-09-20

Legacy Summary#

summary

FDA Review#

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