FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
CHONDROPROTEC
K Number: K961930
·
Decision Oct 15, 1996
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
6
Review Days
151
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Basic Information
- Device Name
- CHONDROPROTEC
- K Number
- K961930
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- The Hymed Group Corp.
- Date Received
- May 17, 1996
- Decision Date
- October 15, 1996
- Product Code
- MGQ
- 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 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 |
| K994339 | HYCURE ORAL / HYCURE ORAL SMART GEL | Mar 22, 2000 | Substantially Equivalent |
| K960686 | HYCOAT | Aug 12, 1996 | Substantially Equivalent for Some Indications |
| K955506 | HYCURE | Jan 17, 1996 | Substantially Equivalent |