FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUGRAFT BGS SYRINGE, MODEL 600-041
K Number: K043172
·
Decision Jan 7, 2005
Classifications
1
FEI Numbers
553
Registration Numbers
553
Same Product Code
738
Applicant Total
9
Review Days
52
Basic Information
- Device Name
- TRUGRAFT BGS SYRINGE, MODEL 600-041
- K Number
- K043172
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OSTEOBIOLOGICS, INC.
- Date Received
- November 16, 2004
- Decision Date
- January 7, 2005
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K032673 | IMMIX PLASTIFILM | Oct 2, 2003 | Substantially Equivalent |
| K030288 | POLYGRAFT BONE GRAFT SUBSTITUTE | Jul 17, 2003 | Substantially Equivalent |
| K024199 | IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP | Mar 14, 2003 | Substantially Equivalent |
| K013429 | ACTAEON PROBE | Jan 11, 2002 | Substantially Equivalent |