510(k) K844765
- Device
- ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN
- Applicant
- LASER SPECTRUM, INC.
- 510(k) number
- K844765
- Product code
- EWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-04-08
- Date received
- 1984-12-07
- Regulation
- 874.4420
- Classification name
- Saw, Surgical, Ent (electric Or Pneumatic)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT E BROWNE
- Address
- 100 S. Wacker Dr. Chicago IL US 60606 60606
FDA Registration Numbers#
- 1422375
- 3012322232
- 3010202439
- 3005067367
- 2020550
- 9611253
- 3003882387
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EWQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K800669 | FELDMAN MINI-SAW, #300000 | KARL STORZ Endoscopy-America, Inc. | 1980-04-21 |
Legacy Summary#
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FDA Review#
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