FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLS MED. PROD. RACINE TYPE ADAPTOR
K Number: K853828
·
Decision Oct 29, 1985
Classifications
1
FEI Numbers
167
Registration Numbers
167
Same Product Code
93
Applicant Total
2
Review Days
46
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Basic Information
- Device Name
- FLS MED. PROD. RACINE TYPE ADAPTOR
- K Number
- K853828
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Fls Medical Products, Inc.
- Date Received
- September 13, 1985
- Decision Date
- October 29, 1985
- Product Code
- BZA
- 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 |
|---|---|---|---|
| BZA | Connector, Airway (Extension) | FDA class 1 | Anesthesiology |
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Other Clearances by Fls Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K831476 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE | Jun 10, 1983 | Substantially Equivalent |