FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
HYCURE ORAL / HYCURE ORAL SMART GEL
K Number: K994339
·
Decision Mar 22, 2000
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
6
Review Days
90
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Basic Information
- Device Name
- HYCURE ORAL / HYCURE ORAL SMART GEL
- K Number
- K994339
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Hymed Group Corp.
- Date Received
- December 23, 1999
- Decision Date
- March 22, 2000
- Product Code
- KGN
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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Other Clearances by The Hymed Group Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K132891 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | Jun 19, 2014 | Substantially Equivalent |
| K061227 | HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVER | Dec 20, 2006 | Substantially Equivalent |
| K961930 | CHONDROPROTEC | Oct 15, 1996 | Substantially Equivalent for Some Indications |
| K960686 | HYCOAT | Aug 12, 1996 | Substantially Equivalent for Some Indications |
| K955506 | HYCURE | Jan 17, 1996 | Substantially Equivalent |