FDA 510(k)
FDA unclassified
Substantially Equivalent for Some Indications
🇺🇸 United States
DERMAPLEX HYDROGEL WOUND DRESSING
K Number: K962513
·
Decision Sep 12, 1996
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
144
Applicant Total
26
Review Days
77
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Basic Information
- Device Name
- DERMAPLEX HYDROGEL WOUND DRESSING
- K Number
- K962513
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Maxxim Medical
- Date Received
- June 27, 1996
- Decision Date
- September 12, 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 |
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|---|---|---|---|
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| K002847 | INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX | May 31, 2001 | Substantially Equivalent |
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| K002933 | STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | Oct 19, 2000 | Substantially Equivalent |
| K990173 | PATHFINDER II ANGIOGRAPHIC CATHETER | Dec 21, 1999 | Substantially Equivalent |
| K992865 | SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE | Oct 13, 1999 | Substantially Equivalent |
| K991615 | POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE | Jul 30, 1999 | Substantially Equivalent |
| K992122 | TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE | Jul 15, 1999 | Substantially Equivalent |