FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

INFANT ELECTROSURGICAL GROUNDING PAD

K Number: K780405 · Decision Apr 5, 1978
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
6
Review Days
23

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Basic Information

Device Name
INFANT ELECTROSURGICAL GROUNDING PAD
K Number
K780405
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
878.4400
Medical Specialty
General, Plastic Surgery
Decision
Substantially Equivalent
Applicant
New Dimensions IN Medicine, Inc.
Date Received
March 13, 1978
Decision Date
April 5, 1978
Product Code
JOS
Advisory Committee
General, Plastic Surgery
Review Advisory Committee
SU
Third Party
N

Classifications

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

Product Code Device Name
JOS Electrode, Electrosurgical

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K822077 RESPIRATION MONITOR TYPE MR-10
K780631 NDM INFANT ECG PACKPAD
K771749 AMALGAM DISPENSER