FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MOLLOY INTUBATING STYLETTE
K Number: K943104
·
Decision Apr 18, 1996
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
31
Applicant Total
1
Review Days
659
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Basic Information
- Device Name
- MOLLOY INTUBATING STYLETTE
- K Number
- K943104
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5790
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Molloy Corp.
- Date Received
- June 29, 1994
- Decision Date
- April 18, 1996
- Product Code
- BSR
- 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 |
|---|---|---|---|
| BSR | Stylet, Tracheal Tube | FDA class 1 | Anesthesiology |
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