FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT
K Number: K904316
·
Decision Oct 11, 1990
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
12
Applicant Total
29
Review Days
20
Basic Information
- Device Name
- NOUVELLE (TM) MODEL #901, SIZES 0-12, LEFT & RIGHT
- K Number
- K904316
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- COLOPLAST CORP.
- Date Received
- September 21, 1990
- Decision Date
- October 11, 1990
- Product Code
- KCZ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| KCZ | Prosthesis, Breast, External, Used With Adhesive | FDA class 1 | General, Plastic Surgery |
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Other Clearances by COLOPLAST CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K132061 | RESTORELLE M, RESTORELLE XL | Aug 2, 2013 | Substantially Equivalent |
| K122968 | NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL 93-6015 | Dec 18, 2012 | Substantially Equivalent |
| K122440 | RESTORELLE L | Nov 19, 2012 | Substantially Equivalent |
| K121457 | SPEEDICATH COMPACT SET (12 FR) | Oct 2, 2012 | Substantially Equivalent |
| 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 |