FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SCHULTZ ENDHOLD
K Number: K833332
·
Decision Oct 31, 1983
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
18
Applicant Total
2
Review Days
34
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Basic Information
- Device Name
- SCHULTZ ENDHOLD
- K Number
- K833332
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5280
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Polyclinic Medical Center
- Date Received
- September 27, 1983
- Decision Date
- October 31, 1983
- Product Code
- JAY
- 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 |
|---|---|---|---|
| JAY | Support, Breathing Tube | FDA class 1 | Anesthesiology |
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Other Clearances by Polyclinic Medical Center
| K Number | Device Name | ||
|---|---|---|---|
| K924935 | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT | Sep 2, 1993 | Substantially Equivalent |