FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
K Number: K083103
·
Decision Feb 26, 2009
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
14
Review Days
129
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Basic Information
- Device Name
- ACRYDERM ANTIMICROBIAL SILVER GEL WOUND DRESSING MODEL #B
- K Number
- K083103
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Acrymed, Inc.
- Date Received
- October 20, 2008
- Decision Date
- February 26, 2009
- 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 Acrymed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091354 | ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING | Oct 21, 2009 | Substantially Equivalent |
| K082459 | ACRYDERM ABSORBENT OXYGEN DRESSING | Sep 19, 2008 | Substantially Equivalent |
| K070333 | ACRYDERM SILVER ANTIMICROBIAL OTC WOUND GEL | Jul 10, 2007 | Substantially Equivalent |
| K061232 | ACRYDERM SILVER ANTIMICROBIAL THIN FILM, MODEL 2006 | Oct 6, 2006 | Substantially Equivalent |
| K011994 | ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 | Nov 8, 2001 | Substantially Equivalent |
| K012116 | ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING | Sep 12, 2001 | Substantially Equivalent |
| K002909 | ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103 | Oct 13, 2000 | Substantially Equivalent |
| K002599 | MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 | Sep 21, 2000 | Substantially Equivalent |
| K991818 | ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045 | Apr 17, 2000 | Substantially Equivalent |
| K992032 | ACRY ISLAND BORDER DRESSING, MODELS 2031, 2032, 2033 | Aug 19, 1999 | Substantially Equivalent |