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

NEEDLE COUNTING

K Number: K771791 · Decision Oct 4, 1977
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
112
Applicant Total
10
Review Days
12

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Basic Information

Device Name
NEEDLE COUNTING
K Number
K771791
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5570
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Applicant
Chase Mfg. Co.
Date Received
September 22, 1977
Decision Date
October 4, 1977
Product Code
MMK
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

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

Product Code Device Name
MMK Container, Sharps

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K791513 ADAMCO DUST COVER
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K790644 SUBMAX
K780033 MATTRESSES, CONDUCTIVE & COVERS
K771792 ENEMA SET
K770900 CAST BRWM, FRACTURE
K770898 FRACTURE CAST BRACE KIT, PLASTIC
K770899 FRACTURE CAST BRACE, POLY
K770173 STOCKINETTE