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510(k) K862564

Device
A.C.L. GUIDE KIT
Applicant
ASPEN LABORATORIES, INC.
510(k) number
K862564
Product code
FZX  
Decision
Substantially Equivalent (SESE)
Decision date
1986-08-18
Date received
1986-07-03
Regulation
878.4800
Classification name
Guide, Surgical, Instrument
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHNSON
Address
P.O. Box 3936 Englewood CO US 80155 80155

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FZX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914715PARALLELING GUIDESImplant Corp. of America1994-02-16
K871413CIVCO STEPPERCIVCO Medical Instruments Co., Inc.1987-07-14
K871503BIOPSY NEEDLE GUIDE KIT, STERILEAmedic USA1987-07-10
K854262MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLYMeadox Surgimed, Inc.1985-12-24
K852402NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZERNorth American Instrument Corp.1985-07-11
K842698BRITISH SPINAL FUSION SETDowns Surgical , Ltd.1984-09-12
K841618THREADING TUBEPlastafil, Inc.1984-08-27
K841619DRILL GUIDEPlastafil, Inc.1984-07-11
K841297TECHMEDICA DRILL GUIDETechmedica, Inc.1984-04-25
K840835STRAITH DRAIN INSERTERSurgical Technology Laboratories, Inc.1984-04-23
K834350ACUFEX DREZ COMMUNICATING DRILL GUIDEAcufex Microsurgical, Inc.1984-03-19
K830720GRAF MENISCAL SUTURE SETAcufex Microsurgical, Inc.1983-06-16
K821618DISPOSABLE NEEDLE HOLDERSMedcare Products1982-06-21
K810888BOUNDARY TUBING HOLDERSThe Buckeye Cellulose Corp.1981-04-23
K810788SURGICAL TUBE HOLDERThe Urology Group1981-04-17

Legacy Summary#

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FDA Review#

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