FDA 510(k)
Substantially Equivalent
🇺🇸 United States
MIDAS REX SURGICAL RUBBER DAM
K Number: K854462
·
Decision Nov 22, 1985
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
12
Review Days
16
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MIDAS REX SURGICAL RUBBER DAM
- K Number
- K854462
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Midas Rex Pneumatic Tools, Inc.
- Date Received
- November 6, 1985
- Decision Date
- November 22, 1985
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by Midas Rex Pneumatic Tools, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972289 | MIDAS REX MOTOR | Sep 12, 1997 | Substantially Equivalent |
| K970965 | MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) | Apr 9, 1997 | Substantially Equivalent |
| K962483 | MIDAS REX III MOTOR | Nov 19, 1996 | Substantially Equivalent |
| K953434 | MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) | May 16, 1996 | Substantially Equivalent |
| K954076 | MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS | Oct 18, 1995 | Substantially Equivalent |
| K953433 | MIDAS REX TELESCOPING SYSTEM | Sep 15, 1995 | Substantially Equivalent |
| K953432 | ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS | Sep 14, 1995 | Substantially Equivalent |
| K952463 | GS & GS20 SURGICAL TOOL SYSTEM | Jul 17, 1995 | Substantially Equivalent |
| K952300 | MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) | May 26, 1995 | Substantially Equivalent |
| K900388 | MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES | May 7, 1990 | Substantially Equivalent |