510(k) K883522
- Device
- Amerimed Ultrasonic Surgical Aspiration Kit
- Applicant
- AMERIMED US CORP.
- 510(k) number
- K883522
- Product code
- LBK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-09-30
- Date received
- 1988-08-17
- Classification name
- Neurosurgical Ultrasonic Instruments
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TODD C CUSHMAN
- Address
- 777 Grant, Suite 305 Denver CO US 80203 80203
FDA Registration Numbers#
- 1721676
- 2648988
- 1722139
- 3003418325
- 3012507533
- 3009116370
- 1220477
- 1319639
- 1722447
- 3004608878
- 3006697299
- 1221053
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LBK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972612 | DISSECTRON PORTABLE UNIT | Satelec | 1997-10-08 |
| K962952 | OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) | Olympus Optical, Co. | 1996-11-29 |
| K884412 | CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. | Valleylab, Inc. | 1988-12-02 |
| K884413 | CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR | Valleylab, Inc. | 1988-12-02 |
| K855138 | BOVIE ULTRASONIC SURGICAL SYSTEM | Clinical Technology Corp. | 1986-11-10 |
| K853143 | COOPER LASER SONICS CUSA MODEL 200 | Cooper Lasersonics, Inc. | 1985-10-16 |