FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MQL 20 ND:YAG OPHTHALMIC LASER
K Number: K884694
·
Decision Nov 30, 1988
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
4
Review Days
21
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Basic Information
- Device Name
- MQL 20 ND:YAG OPHTHALMIC LASER
- K Number
- K884694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- California Laboratories, Inc.
- Date Received
- November 9, 1988
- Decision Date
- November 30, 1988
- Product Code
- LQJ
- 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 |
|---|---|---|---|
| LQJ | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | FDA class 2 | Ophthalmic |
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