FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,

K Number: K060208 · Decision Mar 10, 2006
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
161
Applicant Total
5
Review Days
42

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Basic Information

Device Name
CAREO SAFETY SYRINGE 1CC/ML, MODELS CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,
K Number
K060208
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
880.5860
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Life-Shield Products, Inc.
Date Received
January 27, 2006
Decision Date
March 10, 2006
Product Code
MEG
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
MEG Syringe, Antistick

Similar 510(k) Clearances

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Other Clearances by Life-Shield Products, Inc.

K Number Device Name
K072037 CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML
K061055 CAREO SAFETY SYRINGE FOR U-100 INSULIN
K052397 CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML)
K030976 CAREO RETRACTABLE SAFETY SYRINGE