FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA
K Number: K011032
·
Decision Jul 3, 2001
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
6
Review Days
89
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Basic Information
- Device Name
- SMARTJET BONE GRAFT LIQUID APPLICATOR (SPRAY TIP), MODEL SK/S, SMARTJET BONE GRAFT LIQUID APPLICATOR (DUAL LUMEN CANNULA
- K Number
- K011032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Harvest Technologies, Corp.
- Date Received
- April 5, 2001
- Decision Date
- July 3, 2001
- Product Code
- LYC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
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Other Clearances by Harvest Technologies, Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K121005 | ADIPREP ADIPOSE TRANSFER SYSTEM | Sep 21, 2012 | Substantially Equivalent |
| K103340 | SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM | Dec 6, 2010 | Substantially Equivalent |
| K052925 | SMARTPREP2 CENTRIFUGE SYSTEM | Jan 4, 2006 | Substantially Equivalent |
| K043261 | HARVEST GRAFT DELIVERY SYRINGE | Mar 11, 2005 | Substantially Equivalent |
| K020252 | SMARTJET GRAFTING LIQUID APPLICATOR, MODELS SK/S & LK/2 | Apr 5, 2002 | Substantially Equivalent |