FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BECTON DICKINSON SYRINGES
K Number: K980580
·
Decision Jun 25, 1998
Classifications
1
FEI Numbers
553
Registration Numbers
553
Same Product Code
738
Applicant Total
632
Review Days
128
Basic Information
- Device Name
- BECTON DICKINSON SYRINGES
- K Number
- K980580
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- Date Received
- February 17, 1998
- Decision Date
- June 25, 1998
- Product Code
- FMF
- 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 |
|---|---|---|---|
| FMF | Syringe, Piston | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K001364 | BD DIRECTIGEN FLU A+B | Jun 28, 2000 | Substantially Equivalent |
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| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | Nov 3, 1999 | Substantially Equivalent |
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