FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE

K Number: K922960 · Decision Nov 5, 1992
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
19
Applicant Total
3
Review Days
140

Basic Information

Device Name
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
K Number
K922960
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
884.1550
Medical Specialty
Obstetrics/Gynecology
Decision
Unknown
Statement or Summary
Statement
Applicant
CAMEO, INC.
Date Received
June 18, 1992
Decision Date
November 5, 1992
Product Code
HIO
Advisory Committee
Obstetrics/Gynecology
Review Advisory Committee
OB
Third Party
N

Classifications

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

Product Code Device Name
HIO Sampler, Amniotic Fluid (Amniocentesis Tray)

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Other Clearances by CAMEO, INC.

K Number Device Name
K922961 VARIOUS CAMEO MED PERCUTANEOUS SKIN PREP TRAYS,
K922962 VARIOUS CAMEO MED BASIC BIOPSY TRAYS, DISPOSABLE