FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ASPIRATOR/IRRIGATOR OR I/A UNIT
K Number: K820889
·
Decision May 5, 1982
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
39
Applicant Total
2
Review Days
36
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Basic Information
- Device Name
- ASPIRATOR/IRRIGATOR OR I/A UNIT
- K Number
- K820889
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4360
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Mid Laboratories, Inc.
- Date Received
- March 30, 1982
- Decision Date
- May 5, 1982
- Product Code
- KYG
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | FDA class 1 | Ophthalmic |
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Other Clearances by Mid Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K812857 | CHARLES MICRO PROBE | Feb 5, 1982 | Substantially Equivalent |