FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYPERBARIC PENETRATION EXTENSION SET
K Number: K861315
·
Decision May 21, 1986
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
68
Applicant Total
39
Review Days
43
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Basic Information
- Device Name
- HYPERBARIC PENETRATION EXTENSION SET
- K Number
- K861315
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5470
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Cutter Laboratories, Inc.
- Date Received
- April 8, 1986
- Decision Date
- May 21, 1986
- Product Code
- CBF
- 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 |
|---|---|---|---|
| CBF | Chamber, Hyperbaric | FDA class 2 | Anesthesiology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K834106 | INTRAVENOUS INFUSION CONTROLLER | May 30, 1984 | Substantially Equivalent |
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| K823214 | DOSIMETRIC RELEASE PROGRAM - ADMIN. SET | Jan 12, 1983 | Substantially Equivalent |
| K821326 | CUTTER BOND POLYCARBOXYLATE CEMENT | May 28, 1982 | Substantially Equivalent |
| K813532 | CUTTERBOND ZINC PHOSPHATE CEMENT | Mar 2, 1982 | Substantially Equivalent |
| K802105 | C-BLADE | Sep 16, 1980 | Substantially Equivalent |
| K802104 | C-SPLINT | Sep 16, 1980 | Substantially Equivalent |
| K801652 | TOTAL PARENTERAL NUTRITION SET BAG | Aug 27, 1980 | Substantially Equivalent |