FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

HMD-2000 BATTERY-POWERED MINI-DRILL, THE

K Number: K780645 · Decision May 3, 1978
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
28
Applicant Total
8
Review Days
16

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Basic Information

Device Name
HMD-2000 BATTERY-POWERED MINI-DRILL, THE
K Number
K780645
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
878.4820
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
Medishield, Inc.
Date Received
April 17, 1978
Decision Date
May 3, 1978
Product Code
KIJ
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
OR
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment

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K761020 ANKLE (FREEMAN-SWANSON)
K761021 ANKLE INSTRUMENTS (FREEMAN-SWANSON)
K760668 SELECTATEC SYSTEM