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510(k) K933921

Device
ACUFLEX DISPOSABLE KNIVES
Applicant
ACUFEX MICROSURGICAL, INC.
510(k) number
K933921
Product code
HTS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-26
Date received
1993-08-10
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
LYNNE ARONSON
Address
130 Forbes Blvd. Mansfield MA US 02048 02048

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
K930507CUSTOM ORTHOPAEDIC TRAYS (PACKS)Associated Medical Products Co.1994-02-22
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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