FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING
K Number: K946030
·
Decision Feb 27, 1995
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
12
Review Days
80
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Basic Information
- Device Name
- DERMASSIST(TM) HYDROGEL SATURATED GAUZE DRESSING
- K Number
- K946030
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wilshire Medical Products
- Date Received
- December 9, 1994
- Decision Date
- February 27, 1995
- 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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TENDERWET ACTIVE
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Other Clearances by Wilshire Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K946031 | DERMASSIST(TM) HYDROGEL SATURATEED NON WOVEN DRESSING | Feb 27, 1995 | Substantially Equivalent |
| K944333 | HYDRODERM GEL WOUND DRESSING | Nov 10, 1994 | Substantially Equivalent for Some Indications |
| K941149 | DERMAASSIST HYDROCOLLOID DRESSING | May 20, 1994 | Substantially Equivalent for Some Indications |
| K941216 | HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING | May 20, 1994 | Substantially Equivalent for Some Indications |
| K941005 | DERMASSIST(TM) XEROFORM PETROLATUM DRESSING | Apr 14, 1994 | Substantially Equivalent for Some Indications |
| K940044 | DERMASSIST WET DRESSING, SALINE | Mar 3, 1994 | Substantially Equivalent |
| K936230 | DERMASSIST PETROLATUM GAUZE,USP | Mar 3, 1994 | Substantially Equivalent |
| K940076 | DERMASSIST WET DRESSING, WATER | Mar 3, 1994 | Substantially Equivalent |
| K936234 | DERMASSIST OIL EMULSION NON-ADHERING WOUND DRESSING | Mar 3, 1994 | Substantially Equivalent |
| K935796 | HYDRODERM BREATHABLE TRANSPARENT DRESSING | Feb 2, 1994 | Substantially Equivalent |