FDA 510(k)
FDA class 1
Substantially Equivalent for Some Indications
🇺🇸 United States
HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING
K Number: K941216
·
Decision May 20, 1994
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
12
Review Days
67
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Basic Information
- Device Name
- HYDRODERM EXTRA THIN INTELLIGENT HYDROCOLLIOID DRESSING
- K Number
- K941216
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Wilshire Medical Products
- Date Received
- March 14, 1994
- Decision Date
- May 20, 1994
- Product Code
- KMF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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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 |
| K946030 | DERMASSIST(TM) HYDROGEL SATURATED GAUZE 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 |
| 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 |