FLEXTITIP STYLETTE— 510(k) K950380
Substantially EquivalentPolamedco, Inc.
FDA 510(k) clearance K950380 for FLEXTITIP STYLETTE, Substantially Equivalent on 1995-02-10. Applicant: Polamedco, Inc.. Device class: 1.
Clearance details
- Applicant
- Polamedco, Inc.
- Product code
- Code BSR
- Device class
- Class 1
- Regulation
- 21 CFR 868.5790
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Inglewood, CA, US
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- K943104 — MOLLOY INTUBATING STYLETTE
- K955238 — RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
More clearances from Polamedco, Inc.
view allAdverse events under product code BSR
product code BSR- Death
- 2
- Other
- 1
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.