510(k) K875223

Device
DANNINGER ORTHOPAEDIC AWL
Applicant
DANNINGER MEDICAL TECHNOLOGY, INC.
510(k) number
K875223
Product code
HWJ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-17
Date received
1987-12-22
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 SCHLERF
Address
C/O Buckman Co.Inc. 1000 Burnett Ave.Suite 250 Concord CA US 94520 94520

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
K880045ACROMED AWL/PUNCH, DEPTH GAUGEBuckman Co., 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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