FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
K Number: K090026
·
Decision Mar 31, 2009
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
126
Applicant Total
9
Review Days
85
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Basic Information
- Device Name
- CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
- K Number
- K090026
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hem Con Medical Technologies, Inc.
- Date Received
- January 5, 2009
- Decision Date
- March 31, 2009
- Product Code
- QSY
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| QSY | Hemostatic Wound Dressing Without Thrombin Or Other Biologics | FDA unclassified | Unknown |
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Other Clearances by Hem Con Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K153582 | Prometheus ChitoGauze XR PRO | May 25, 2016 | Substantially Equivalent |
| K150916 | HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO | Nov 10, 2015 | Substantially Equivalent |
| K103641 | GUARDACARE | Jun 16, 2011 | Substantially Equivalent |
| K111163 | CHITOGAUZE FUSION | May 17, 2011 | Substantially Equivalent |
| K102546 | CHITOGAUZE | Nov 17, 2010 | Substantially Equivalent |
| K092357 | CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 | Aug 25, 2009 | Substantially Equivalent |
| K072486 | MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC | Aug 6, 2008 | Substantially Equivalent |
| K080818 | HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING | May 15, 2008 | Substantially Equivalent |