FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EZ TAC FILTER
K Number: K870531
·
Decision Apr 10, 1987
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
101
Applicant Total
5
Review Days
63
Basic Information
- Device Name
- EZ TAC FILTER
- K Number
- K870531
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5900
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- John F. Greer Co., Inc.
- Date Received
- February 6, 1987
- Decision Date
- April 10, 1987
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EXB), ordered by most recent decision date.
Heylo System
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
SmartBag (SmartPouch)
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
OSTOM-I ALERT
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
LAKE OSTOMY CARE SET
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ODOR-END EMERGENCY CLEAN UP POWDER
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology