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510(k) K932216

Device
C-SECTION, LABOR & DELIVERY TRAYS (PACKS)
Applicant
ASSOCIATED MEDICAL PRODUCTS CO.
510(k) number
K932216
Product code
MLS  
Decision
Substantially Equivalent - Kit (SESK)
Decision date
1994-04-19
Date received
1993-05-07
Regulation
884.4530
Classification name
Labor And Delivery Kit
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
SCOTT WEISS
Address
3250 Gorham Ave. St. Louis Park MN US 55426 55426

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MLS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961993BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT)Devon Industries, Inc.1996-07-03
K960243CPR C-SECTION DELIVERY PACKCustom Pack Reliability1996-05-23
K940518C-SECTION TRAYCush Medical Products1994-08-18
K936120LABOR AND DELIVERY TRAYCush Medical Products1994-03-30
K931722CARAPACE LABOR AND DELIVERY SETSCarapace, Inc.1994-03-23

Legacy Summary#

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FDA Review#

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