510(k) K962952
- Device
- OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)
- Applicant
- OLYMPUS OPTICAL, CO.
- 510(k) number
- K962952
- Product code
- LBK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-29
- Date received
- 1996-07-30
- Regulation
- 510(k) Premarket Notification
- Classification name
- Device, Neurosurgical Fragmentation And Aspiration
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Neurology
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN D GOLDSTEIN-FALK
- Address
- 55 Northern Blvd., Suite 410 Great Neck, NY US 11021 11021
FDA Registration Numbers#
- 1721676
- 2648988
- 1722139
- 3003418325
- 3012507533
- 3009116370
- 1220477
- 1319639
- 1722447
- 3004608878
- 3006697299
- 1221053
Source Documents#
Other 510(k) Records For Product Code LBK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972612 | DISSECTRON PORTABLE UNIT | Satelec | 1997-10-08 |
| 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 |
| K883522 | AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT | Amerimed US Corp. | 1988-09-30 |
| K855138 | BOVIE ULTRASONIC SURGICAL SYSTEM | Clinical Technology Corp. | 1986-11-10 |
| K853143 | COOPER LASER SONICS CUSA MODEL 200 | Cooper Lasersonics, Inc. | 1985-10-16 |
Legacy Summary#
summary
FDA Review#
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