FDA 510(k)
FDA class 2
Substantially Equivalent
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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 | Device Class | Medical Specialty |
|---|---|---|---|
| MEG | Syringe, Antistick | FDA class 2 | General Hospital |
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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 | Aug 8, 2007 | Substantially Equivalent |
| K061055 | CAREO SAFETY SYRINGE FOR U-100 INSULIN | Jul 10, 2006 | Substantially Equivalent |
| K052397 | CAREO SAFETY SYRINGE (3CC/ML, 5CC/ML, 10CC/ML) | Dec 22, 2005 | Substantially Equivalent |
| K030976 | CAREO RETRACTABLE SAFETY SYRINGE | May 30, 2003 | Substantially Equivalent |