FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
K Number: K955657
·
Decision Mar 12, 1996
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
24
Applicant Total
2
Review Days
91
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Basic Information
- Device Name
- NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE
- K Number
- K955657
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- North State Plastics, Inc.
- Date Received
- December 12, 1995
- Decision Date
- March 12, 1996
- 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
Other 510(k) clearances with the same product code (BYP), ordered by most recent decision date.
TRUZONE PFM DISPOSABLE MOUTHPIECE
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BREATHING MOUTHPIECE
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AEROCHAMBER
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SAFE-T-SHIELD MOUTHPIECE
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FDA Class 1
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INHALATION AID
FDA 510(k)
FDA Class 1
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MP-4400 MOUTHPIECE-FLANGE SEAL
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by North State Plastics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955656 | NORTH STATE PLASTICS AEROSOL TEE | Mar 6, 1996 | Substantially Equivalent |