FDA 510(k)
Substantially Equivalent
🇺🇸 United States
REXTON
K Number: K823075
·
Decision Nov 8, 1982
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
14
Review Days
20
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Basic Information
- Device Name
- REXTON
- K Number
- K823075
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Argosy Intl. (Usa), Inc.
- Date Received
- October 19, 1982
- Decision Date
- November 8, 1982
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- Third Party
- N
Other Clearances by Argosy Intl. (Usa), Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K791548 | REXTON HS(HEARING SYSTEM) | Sep 28, 1979 | Substantially Equivalent |
| K781095 | HEARING AID, BEHIND THE EAR | Jul 17, 1978 | Substantially Equivalent |
| K781094 | HEARING AID, EYEGLASS | Jul 17, 1978 | Substantially Equivalent |
| K781096 | HEARING AID, EYEGLASS, B-12 | Jul 17, 1978 | Substantially Equivalent |
| K780921 | MM-CE DM (BEHIND THE EAR) | Jun 14, 1978 | Substantially Equivalent |
| K780914 | PM 25 PP (BODY AID) | Jun 14, 1978 | Substantially Equivalent |
| K780920 | MM-CE 11 (BEHIND THE EAR) | Jun 14, 1978 | Substantially Equivalent |
| K780916 | 780 UE (BEHIND THE EAR) | Jun 14, 1978 | Substantially Equivalent |
| K780917 | PRIMO CE (BEHIND THE EAR) | Jun 14, 1978 | Substantially Equivalent |
| K780915 | 780 SE (BEHIND THE EAR) | Jun 14, 1978 | Substantially Equivalent |