NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE
FDA 510(k) clearance K831476 · decided 1983-06-10
Clearance details
- K-number
- K831476
- Device name
- NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE
- Applicant
- Fls Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-05-09
- Decision date
- 1983-06-10
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- BTQ
- Device class
- 1
- Regulation number
- 868.5100
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (K940320) | Ad-Tech Medical Instrument Corp | 1995-09-19 |
| NASOPHARYNGEAL AIRWAY (K921353) | Coast Medical Corp. | 1992-06-11 |
| NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY (K911784) | North American Sterilization & Packaging Co. | 1991-09-23 |
| ROBERTAZZI NASOPHARYNGEAL AIRWAY (K903618) | Eastmed Enterprises, Inc. | 1991-01-08 |
| POLAMEDCO NASOPAHARYNGEAL AIRWAY (K900456) | Polamedco, Inc. | 1990-04-19 |
| CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY (K901279) | Chatham Industries | 1990-03-28 |
| SUNDERLAND NASAL TUBE (K883668) | Exmoor Plastics , Ltd. | 1988-11-21 |
| RORERTAZZI NASOPHARYNGEAL AIRWAY (K873949) | Penn Medical Devices, Inc. | 1987-10-20 |
| NASOPHARYNGEAL AIRWAY (K871673) | Harding Industries, Inc. | 1987-06-15 |
| STERILE NASOPHARYNGEAL AIRWAY (K853162) | Inmed Corp. | 1985-08-06 |
| NASOPHARYNGEAL AIRWAY-ROBERTAZZI (K850644) | Dryden Corp. | 1985-03-21 |
| LINDER NASOPHARYNGEAL AIRWAY (K843524) | Polamedco, Inc. | 1984-10-04 |
Recalls involving this device
No recalls on record reference this clearance.