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510(k) K880045

Device
ACROMED AWL/PUNCH, DEPTH GAUGE
Applicant
BUCKMAN CO., INC.
510(k) number
K880045
Product code
HWJ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-17
Date received
1988-01-06
Regulation
888.4540
Classification name
Awl
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DAVID W SCHLERF
Address
921 Calle Verde Martinez CA US 94553 94553

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HWJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K895587CROSS MEDICAL PRODUCT PEDICLE AWLCross Medical Products, Inc.1990-01-04
K875223DANNINGER ORTHOPAEDIC AWLDanninger Medical Technology, Inc.1988-02-17
K870779ACROMED WALLIE-HEINIG TROCHARBuckman Co., Inc.1987-03-09

Legacy Summary#

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FDA Review#

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