FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMALGAMATOR MODEL SDC--
K Number: K791410
·
Decision Sep 19, 1979
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
14
Applicant Total
12
Review Days
69
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Basic Information
- Device Name
- AMALGAMATOR MODEL SDC--
- K Number
- K791410
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3100
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Sierra Laboratories, Inc.
- Date Received
- July 12, 1979
- Decision Date
- September 19, 1979
- Product Code
- EFD
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EFD | Amalgamator, Dental, Ac-Powered | FDA class 1 | Dental |
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| K934052 | ALPINE REUSABLE LEG BAGS | Jan 7, 1994 | Substantially Equivalent |
| K931156 | CONE CATH | Jul 1, 1993 | Substantially Equivalent |
| K901000 | URO TEX URINALS | Mar 26, 1990 | Substantially Equivalent |
| K883057 | COMFORT CATH MALE EXTERNAL CATHETER | Aug 2, 1988 | Substantially Equivalent |
| K873039 | MODEL 820 TOP=TRAK | Feb 11, 1988 | Substantially Equivalent |
| K832450 | URO-TEX MALE EXTERNAL CATHETER | Oct 14, 1983 | Substantially Equivalent |