FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
M-K HYDROGEL DRESSING
K Number: K940409
·
Decision Jul 11, 1994
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
4
Review Days
165
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Basic Information
- Device Name
- M-K HYDROGEL DRESSING
- K Number
- K940409
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Mason-Keller Corp.
- Date Received
- January 27, 1994
- Decision Date
- July 11, 1994
- 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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