FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
K Number: K955495
·
Decision Jun 27, 1996
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
26
Review Days
209
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Basic Information
- Device Name
- RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
- K Number
- K955495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rusch, Inc.
- Date Received
- December 1, 1995
- Decision Date
- June 27, 1996
- Product Code
- BTR
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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