FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
EASY EYES TM LENS CARRYING CASE
K Number: K853870
·
Decision Dec 10, 1985
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
73
Applicant Total
9
Review Days
84
Basic Information
- Device Name
- EASY EYES TM LENS CARRYING CASE
- K Number
- K853870
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- APPLIED LABORATORIES, INC.
- Date Received
- September 17, 1985
- Decision Date
- December 10, 1985
- Product Code
- HPX
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| HPX | Lens, Contact (Polymethylmethacrylate) | FDA unclassified | Unknown |
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Other Clearances by APPLIED LABORATORIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K873825 | GE LEXAN 144R 112 | Mar 24, 1988 | Substantially Equivalent |
| K873822 | MOBAY (BAYER) MERLON M-40 (H)F 1112 | Mar 24, 1988 | Substantially Equivalent |
| K873823 | MOBAY (BAYER) MAKROLON 2658 3291 | Mar 24, 1988 | Substantially Equivalent |
| K873820 | MOBAY (BAYER) MAKROLON 2658 1112 | Mar 24, 1988 | Substantially Equivalent |
| K873821 | GE NORYL 731-80089S | Mar 24, 1988 | Substantially Equivalent |
| K873824 | RED #467, #457, BLUE #437, GREEN #447 MINDEL S1000 | Mar 24, 1988 | Substantially Equivalent |
| K871714 | KESTREL CONTACT LENS CASE | May 26, 1987 | Substantially Equivalent |
| K860677 | EASY EYES TM LENS CARRYING CASE | May 29, 1986 | Substantially Equivalent |