FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
COMPEED PSORIASIS DRESSING
K Number: K982493
·
Decision Jan 28, 1999
Classifications
1
FEI Numbers
402
Registration Numbers
403
Same Product Code
861
Applicant Total
29
Review Days
195
Basic Information
- Device Name
- COMPEED PSORIASIS DRESSING
- K Number
- K982493
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- COLOPLAST CORP.
- Date Received
- July 17, 1998
- Decision Date
- January 28, 1999
- 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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|---|---|---|---|
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| K112386 | EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM | Sep 8, 2011 | Substantially Equivalent |
| K072808 | SPEEDICATH COMPACT | Nov 9, 2007 | Substantially Equivalent |
| K052229 | COLOPLAST OSTOMY ROD, MODEL 12814 | Oct 13, 2006 | Substantially Equivalent |
| K033869 | CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) | May 17, 2004 | Substantially Equivalent |
| K022416 | CONTREET FOAM ADHESIVE/NON-ADHESIVE | Feb 3, 2003 | Substantially Equivalent |
| K023254 | SPEEDICATH | Jan 27, 2003 | Substantially Equivalent |