FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
SUCTION ORA-SWAB(R) BRUSH KIT
K Number: K901806
·
Decision Aug 15, 1990
Classifications
1
FEI Numbers
111
Registration Numbers
111
Same Product Code
283
Applicant Total
31
Review Days
117
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Basic Information
- Device Name
- SUCTION ORA-SWAB(R) BRUSH KIT
- K Number
- K901806
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Unknown
- Applicant
- Sage Products, Inc.
- Date Received
- April 20, 1990
- Decision Date
- August 15, 1990
- Product Code
- EIA
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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Other Clearances by Sage Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972705 | RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC | Apr 30, 1998 | Substantially Equivalent |
| K980490 | SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPS | Feb 24, 1998 | Substantially Equivalent |
| K973911 | 2 GALLON ALTERNATE CARE SHARPS CONTAINER | Oct 29, 1997 | Substantially Equivalent |
| K972279 | SHARPS SHUTTLE | Aug 29, 1997 | Substantially Equivalent |
| K970135 | NITRILE GLOVES | Aug 25, 1997 | Substantially Equivalent |
| K972302 | POCKET COUNT OR SAFETCOUNT | Jul 25, 1997 | Substantially Equivalent |
| K964168 | PROCEDURE SPECIFIC KITS | Mar 3, 1997 | Substantially Equivalent |
| K963986 | STP SYSTEM PVA WITH ZINC | Nov 8, 1996 | Substantially Equivalent |
| K964026 | STP SYSTEM - SAF | Nov 7, 1996 | Substantially Equivalent |
| K964027 | STP SYSTEM-PVA WITH MERCURY | Nov 1, 1996 | Substantially Equivalent |