510(k) K800669
- Device
- FELDMAN MINI-SAW, #300000
- Applicant
- KARL STORZ ENDOSCOPY-AMERICA, INC.
- 510(k) number
- K800669
- Product code
- EWQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-04-21
- Date received
- 1980-03-26
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
|---|---|---|---|
| K844765 | ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN | Laser Spectrum, Inc. | 1985-04-08 |
Legacy Summary#
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FDA Review#
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