FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MPM HYDROGEL DRESSING (NON-STERILE)
K Number: K962160
·
Decision Jun 26, 1996
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
9
Review Days
22
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Basic Information
- Device Name
- MPM HYDROGEL DRESSING (NON-STERILE)
- K Number
- K962160
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mpm Medical., Inc.
- Date Received
- June 4, 1996
- Decision Date
- June 26, 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 |
Similar 510(k) Clearances
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SILVERSEAL
FDA 510(k)
FDA Unclassified
·Unknown
TENDERWET ACTIVE
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Mpm Medical., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060340 | ORAMAGIC PLUS ORAL WOUND RINSE | May 10, 2006 | Substantially Equivalent |
| K024180 | ORAMAGICRX ORAL WOUND RINSE | Mar 14, 2003 | Substantially Equivalent |
| K020540 | REGENECARE WOUND GEL | Nov 1, 2002 | Substantially Equivalent |
| K992074 | MPM REGENECARE WOUND GEL | Dec 23, 1999 | Substantially Equivalent |
| K952276 | MPM HYDROGEL DRESSING | Jun 30, 1995 | Substantially Equivalent |
| K942798 | MPM HYDROGEL | Jul 11, 1994 | Substantially Equivalent for Some Indications |
| K930560 | MPM HYDROGEL SATURATED DRESSING | Jul 8, 1993 | Substantially Equivalent |
| K926044 | MPM WET DRESSING (SALINE) | Apr 8, 1993 | Substantially Equivalent |