FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SILVER FOAM WOUND DRESSING
K Number: K914579
·
Decision Feb 21, 1992
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
13
Review Days
128
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Basic Information
- Device Name
- SILVER FOAM WOUND DRESSING
- K Number
- K914579
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vitaphore Corp.
- Date Received
- October 16, 1991
- Decision Date
- February 21, 1992
- Product Code
- FRO
- 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 |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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Other Clearances by Vitaphore Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K913148 | COLLAGEN SHIELD FOR ACUTE CARE | Oct 15, 1991 | Substantially Equivalent |
| K895920 | VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS | Jun 6, 1991 | Substantially Equivalent |
| K902558 | COLLAGEN SHIELD FOR ACUTE CARE | Aug 17, 1990 | Substantially Equivalent |
| K891993 | COLLAGEN NEUROSPONGE | Mar 23, 1990 | Substantially Equivalent |
| K896455 | VITACHOICE WOUND DRESSING | Feb 15, 1990 | Substantially Equivalent |
| K896046 | VITAPATCH CATH. SECUREMENT DEVICE W/CHLORHEXIDINE | Jan 11, 1990 | Substantially Equivalent |
| K895993 | VITAPATCH ANTIMICROBIAL CATHETER SECUREMENT DEVICE | Jan 11, 1990 | Substantially Equivalent |
| K890435 | VITAACCESS CATHETER INTRODUCER KIT | Mar 29, 1989 | Unknown |
| K882100 | VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT | Jul 13, 1988 | Substantially Equivalent |
| K872998 | VITAACCESS (TM) CATHETER INTRODUCER SYSTEM | Mar 24, 1988 | Substantially Equivalent |