FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MINILAX SET
K Number: K863012
·
Decision Oct 1, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
21
Review Days
54
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Basic Information
- Device Name
- MINILAX SET
- K Number
- K863012
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Sds Dental, Inc.
- Date Received
- August 8, 1986
- Decision Date
- October 1, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Other Clearances by Sds Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K990546 | DELSONIC 2000 | Nov 5, 1999 | Substantially Equivalent |
| K990545 | JETSONIC 2000 | Aug 11, 1999 | Substantially Equivalent |
| K964619 | DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) | Jan 22, 1997 | Substantially Equivalent |
| K902864 | SURGICAL LIGHTING-CENTRA 450 | Sep 10, 1990 | Substantially Equivalent |
| K902865 | BAUMER SURGICAL TABLE | Sep 10, 1990 | Substantially Equivalent |
| K863011 | DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II | Oct 10, 1986 | Substantially Equivalent |
| K863021 | CM-II, CM-I WATER UNIT | Oct 1, 1986 | Substantially Equivalent |
| K863016 | DENTATUS L SET | Oct 1, 1986 | Substantially Equivalent |
| K863007 | EUROFLEX F-IV, ISOFLEX III | Oct 1, 1986 | Substantially Equivalent |
| K863015 | ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT | Oct 1, 1986 | Substantially Equivalent |