FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASPIREX - BONE MARROW ASPIRATE KIT
K Number: K041991
·
Decision Sep 16, 2004
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
747
Applicant Total
10
Review Days
55
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Basic Information
- Device Name
- ASPIREX - BONE MARROW ASPIRATE KIT
- K Number
- K041991
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isotis Orthobiologics, Inc.
- Date Received
- July 23, 2004
- Decision Date
- September 16, 2004
- 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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| K050642 | ORTHOBLAST II PUTTY AND PASTE | Dec 5, 2005 | Substantially Equivalent |
| K052098 | CONNEXUS, .5CC, MODEL 023000-005 | Sep 7, 2005 | Substantially Equivalent |
| K043573 | DYNAGRAFT II DENTAL | Jul 29, 2005 | Substantially Equivalent |
| K050690 | CONNEXUS | Jul 7, 2005 | Substantially Equivalent |
| K040419 | DYNAGRAFT II | Mar 25, 2005 | Substantially Equivalent |
| K042706 | OSSATURA DENTAL | Oct 20, 2004 | Substantially Equivalent |