FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SHELL KRATON THERMO-PLASTIC RUBBER COMP.
K Number: K803069
·
Decision Dec 22, 1980
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
24
Applicant Total
14
Review Days
17
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Basic Information
- Device Name
- SHELL KRATON THERMO-PLASTIC RUBBER COMP.
- K Number
- K803069
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Warren E. Collins, Inc.
- Date Received
- December 5, 1980
- Decision Date
- December 22, 1980
- Product Code
- BYP
- 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 |
|---|---|---|---|
| BYP | Mouthpiece, Breathing | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
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NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
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AEROCHAMBER
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SAFE-T-SHIELD MOUTHPIECE
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INHALATION AID
FDA 510(k)
FDA Class 1
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Other Clearances by Warren E. Collins, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925459 | GS-MODULAR (GOLD STANDARD - MODULAR) | Feb 4, 1994 | Substantially Equivalent |
| K912946 | COLLINS DIGITAL PULMONARY MANOMETER | Jan 15, 1992 | Substantially Equivalent |
| K871151 | THE SPIRA ELEKTRO 2 | May 15, 1987 | Substantially Equivalent |
| K861227 | COLLINS PNEUMOTACH PFT SYSTEM | Jun 5, 1986 | Substantially Equivalent |
| K852102 | COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM | Jul 31, 1985 | Substantially Equivalent |
| K831780 | METABOLIC EXERCISE TESTING SYSTEM | Sep 12, 1983 | Substantially Equivalent |
| K831777 | COLLINS DS | Aug 31, 1983 | Substantially Equivalent |
| K831778 | RS-RESIDUAL VOLUME SYSTEM | Aug 31, 1983 | Substantially Equivalent |
| K831779 | COLLINS EAGLE II | Aug 26, 1983 | Substantially Equivalent |
| K803053 | APEXLINE OF PULMONARY FUNCT. INSTRUM. | Dec 22, 1980 | Substantially Equivalent |