FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
C.C.-PAK
K Number: K800635
·
Decision Apr 10, 1980
Classifications
1
FEI Numbers
331
Registration Numbers
331
Same Product Code
83
Applicant Total
26
Review Days
20
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Basic Information
- Device Name
- C.C.-PAK
- K Number
- K800635
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Respiratory Care, Inc.
- Date Received
- March 21, 1980
- Decision Date
- April 10, 1980
- Product Code
- JOL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| JOL | Catheter And Tip, Suction | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOL), ordered by most recent decision date.
STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014
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PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION
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WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION
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STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
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HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE
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Other Clearances by Respiratory Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K892230 | RCI VIRAL/BACTERIAL FILTER | Aug 28, 1989 | Substantially Equivalent |
| K884150 | MODIFIED CONCHATHERM III CONTROLLED HEATER | Nov 21, 1988 | Substantially Equivalent |
| K881625 | CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL | Jun 21, 1988 | Substantially Equivalent |
| K864147 | AQUAVALVE | Dec 5, 1986 | Substantially Equivalent |
| K863955 | COLBY LEVEL ALARM | Nov 7, 1986 | Substantially Equivalent |
| K861555 | CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT | Jun 5, 1986 | Substantially Equivalent |
| K834151 | CONCHATHERM LHF HUMIDIFIER HEATER | Jan 13, 1984 | Substantially Equivalent |
| K833974 | AQUAPAK 020 HUMIDIFIER ADAPTER | Dec 16, 1983 | Substantially Equivalent |
| K832453 | SLIMB SINGLE LIMB BREATHING CIRCUIT | Oct 27, 1983 | Substantially Equivalent |
| K811524 | AQUACADE | Jul 1, 1981 | Substantially Equivalent |