FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIXATION DEVICE, TRACH TUBE
K Number: K882694
·
Decision Aug 15, 1988
Classifications
1
FEI Numbers
142
Registration Numbers
142
Same Product Code
46
Applicant Total
10
Review Days
49
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Basic Information
- Device Name
- FIXATION DEVICE, TRACH TUBE
- K Number
- K882694
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5770
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Bioseal
- Date Received
- June 27, 1988
- Decision Date
- August 15, 1988
- Product Code
- CBH
- 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 |
|---|---|---|---|
| CBH | Device, Fixation, Tracheal Tube | FDA class 1 | Anesthesiology |
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Other Clearances by Bioseal
| K Number | Device Name | ||
|---|---|---|---|
| K893814 | SURGICAL INSTRUMENT KIT, DISPOSABLE | Aug 10, 1989 | Substantially Equivalent |
| K882695 | RUBBER BAND, STERILE | Oct 13, 1988 | Substantially Equivalent |
| K882696 | DERMICEL, MONTGOMERY STRAP | Aug 26, 1988 | Substantially Equivalent |
| K882710 | INTESTINAL SPONGES | Aug 3, 1988 | Substantially Equivalent |
| K882708 | GAUZE SPONGE, X-RAY DETECTABLE | Aug 3, 1988 | Substantially Equivalent |
| K882709 | TONSIL SPONGE, X-RAY DETECTABLE, W/STRING | Aug 3, 1988 | Substantially Equivalent |
| K882707 | GAUZE PACKING, X-RAY DETECTABLE | Aug 3, 1988 | Substantially Equivalent |
| K882711 | GAUZE SPONGE 12PLY | Aug 3, 1988 | Substantially Equivalent |
| K882712 | STICK SPONGE | Aug 3, 1988 | Substantially Equivalent |