ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
FDA 510(k) clearance K965016 · decided 1997-12-02
Clearance details
- K-number
- K965016
- Device name
- ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
- Applicant
- Gibeck, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-16
- Decision date
- 1997-12-02
- Days to decision
- 351 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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