FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACTIVE LIFE
K Number: K833625
·
Decision Nov 28, 1983
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
101
Applicant Total
81
Review Days
45
Basic Information
- Device Name
- ACTIVE LIFE
- K Number
- K833625
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Convatec, A Division of E.R. Squibb & Sons
- Date Received
- October 14, 1983
- Decision Date
- November 28, 1983
- Product Code
- EXB
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EXB | Collector, Ostomy | FDA class 1 | Gastroenterology, Urology |
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Other Clearances by Convatec, A Division of E.R. Squibb & Sons
| K Number | Device Name | ||
|---|---|---|---|
| K013814 | ABSORBENT ANTIMICROBIAL WOUND DRESSING | Jun 21, 2002 | Substantially Equivalent |
| K990964 | SIGNADRESS DUODERM DRESSING | May 18, 1999 | Substantially Equivalent |
| K984388 | HA ABSORBENT WOUND DRESSING | Mar 3, 1999 | Substantially Equivalent |
| K980720 | NONWOVEN PAD | Apr 15, 1998 | Substantially Equivalent |
| K980382 | NON-WOVEN COMPRESS | Mar 9, 1998 | Substantially Equivalent for Some Indications |
| K974823 | NONWOVEN DRESSING | Feb 20, 1998 | Substantially Equivalent for Some Indications |
| K974205 | KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON | Feb 6, 1998 | Substantially Equivalent |
| K974304 | GERMICIDAL CLOTH | Jan 13, 1998 | Substantially Equivalent |
| K973632 | DUODERM CGF CONTROL GEL FORMULA DRESSING | Dec 22, 1997 | Substantially Equivalent for Some Indications |
| K972530 | CONVATEC ODOR CONTROL WOUND DRESSING | Oct 1, 1997 | Substantially Equivalent |