SHERIDAN/ENDO-PAK
FDA 510(k) clearance K842635 · decided 1984-07-25
Clearance details
- K-number
- K842635
- Device name
- SHERIDAN/ENDO-PAK
- Applicant
- Sheridan Catheter Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-09
- Decision date
- 1984-07-25
- Days to decision
- 16 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.