FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
HYDRODERM BREATHABLE TRANSPARENT DRESSING
K Number: K935796
·
Decision Feb 2, 1994
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
79
Applicant Total
12
Review Days
57
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Basic Information
- Device Name
- HYDRODERM BREATHABLE TRANSPARENT DRESSING
- K Number
- K935796
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wilshire Medical Products
- Date Received
- December 7, 1993
- Decision Date
- February 2, 1994
- Product Code
- MGP
- 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 |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | FDA unclassified | Unknown |
Similar 510(k) Clearances
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FASTSEAL CHEST WOUND DRESSING
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SIMPLICARE TRANSPARENT WOUND DRESSING
FDA 510(k)
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DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS
FDA 510(k)
FDA Unclassified
·Unknown
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 |
| 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 |