510(k) K102127
- Device
- ENDOTRACHEAL TUBE CHANGERS
- Applicant
- INSTRUMENTATION INDUSTRIES, INC.
- 510(k) number
- K102127
- Product code
- LNZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-08-27
- Date received
- 2010-07-29
- Regulation
- 868.5730
- Classification name
- Changer, Tube, Endotracheal
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DORIS WALTER
- Address
- 2990 Industrial Blvd. Bethel Park PA US 15102 15102
FDA Registration Numbers#
- 2518436
- 3020460367
Source Documents#
Legacy Summary#
summary
FDA Review#
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