510(k) K971348
- Device
- FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
- Applicant
- GREEN FIELD MEDICAL SOURCING, INC.
- 510(k) number
- K971348
- Product code
- CAO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-02-27
- Date received
- 1997-04-10
- Regulation
- 868.5650
- Classification name
- Airway, Esophageal (obturator)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD R GORSUCH
- Address
- 910 Boston Tpke. Rd. Shrewsbury MA US 01545 01545
FDA Registration Numbers#
- 9681384
- 3020460367
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CAO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K894032 | EVAC-TUBE | Sharn, Inc. | 1989-08-31 |
| K875226 | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE | Sheridan Catheter Corp. | 1988-01-19 |
| K864200 | VETA/VENTED ESOPHAGEAL TUBE AIRWAY | Cranco Co. | 1987-03-17 |
| K863172 | RESPIRONICS PTL REVIVEEASY | Respironics, Inc. | 1986-11-04 |
| K761195 | ESOPHAGEAL OBTURATION AIRWAY | Mckesson Corp. | 1976-12-09 |
Legacy Summary#
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FDA Review#
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