FDA.reportPublic FDA data

510(k) K851339

Device
PRECISION HARVEST & INLAY INSTRUMENT SET
Applicant
CONCEPT, INC.
510(k) number
K851339
Product code
HWK  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-02
Date received
1985-04-03
Regulation
888.4540
Classification name
Trephine
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PENNY C RASMUSSEN
Address
12707 U.S. 19 S. Clearwater FL US 33546 33546

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases