510(k) K864166
- Device
- 25 WATT CARBON DIOXIDE MEDICAL LASER FOR NEUROLOGY
- Applicant
- WECK SURGICAL SYSTEMS
- 510(k) number
- K864166
- Product code
- LKW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-10
- Date received
- 1986-10-23
- Regulation
- 510(k) Premarket Notification
- Classification name
- Laser, Neurosurgical
- 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
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ZBIGNIEW DROZDOWICZ
- Address
- 686 Old Willets Path Hauppauge NY US 11788 11788
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LKW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K875042 | ND:YAG 100 SURGICAL LASER FOR NEURO & PULMONARY | Surgilase, Inc. | 1988-06-24 |
| K880172 | MODEL 4900 ND:YAG LASER FOR NEUROSURGERY APPLICA. | Cooper Lasersonics, Inc. | 1988-03-11 |
| K853580 | MEDILAS 2 | Endo Lase, Inc. | 1986-02-13 |
| K844440 | MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL | Cooper Lasersonics, Inc. | 1985-05-09 |
Legacy Summary#
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FDA Review#
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