FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MOUTHPIECE SEAL
K Number: K761297
·
Decision Jan 3, 1977
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
24
Applicant Total
5
Review Days
13
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Basic Information
- Device Name
- MOUTHPIECE SEAL
- K Number
- K761297
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Oem Medical Div.
- Date Received
- December 21, 1976
- Decision Date
- January 3, 1977
- 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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TRUZONE PFM DISPOSABLE 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
·Anesthesiology
Other Clearances by Oem Medical Div.
| K Number | Device Name | ||
|---|---|---|---|
| K924570 | OEM MULTI-VAC POWERED SUCTION PUMP | Aug 5, 1993 | Substantially Equivalent |
| K925893 | OEM MEDICAL ADULT ANESTHESIA BREATHING CIRCUIT | Mar 12, 1993 | Substantially Equivalent |
| K922748 | GUEDEL AIRWAY | Jul 10, 1992 | Substantially Equivalent |
| K811855 | SKIN SCRUB KITS | Jul 31, 1981 | Substantially Equivalent |