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510(k) K930507

Device
CUSTOM ORTHOPAEDIC TRAYS (PACKS)
Applicant
ASSOCIATED MEDICAL PRODUCTS CO.
510(k) number
K930507
Product code
HTS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-22
Date received
1993-02-01
Regulation
888.4540
Classification name
Knife, Orthopedic
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
SCOTT WIEST
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 HTS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K933921ACUFLEX DISPOSABLE KNIVESAcufex Microsurgical, Inc.1994-01-26
K882525SPINAL MICROKNIFEKarlin Technology, Inc.1988-09-22
K873711RETROGRADE KNIFE, DISPOSABLE #TM-1613Arthropedics, Inc.1987-11-02
K873713TRIANGULAR KNIFE, DISPOSABLE #TM-1611Arthropedics, Inc.1987-11-02
K873714BANANA KNIFE, DISPOSABLE #TM-1612Arthropedics, Inc.1987-11-02
K873712STANDARD KNIFE, DISPOSABLE #TM-1610Arthropedics, Inc.1987-10-15
K842820ARTHROSCOPY KNIVESMedtech Industries, Inc.1984-08-14
K771851ARTHROSCOPE OPERATIVE KNIFE SETRichard Wolf Medical Instruments Corp.1977-10-27

Legacy Summary#

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FDA Review#

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