FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MONARCH IOL DELIVERY SYSTEM
K Number: K981571
·
Decision Jul 9, 1998
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
38
Applicant Total
47
Review Days
66
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Basic Information
- Device Name
- MONARCH IOL DELIVERY SYSTEM
- K Number
- K981571
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alcon Laboratories
- Date Received
- May 4, 1998
- Decision Date
- July 9, 1998
- Product Code
- KYB
- 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 |
|---|---|---|---|
| KYB | Lens, Guide, Intraocular | FDA class 1 | Ophthalmic |
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Other Clearances by Alcon Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K062624 | NEXT GENERATION LASER | Nov 5, 2007 | Substantially Equivalent |
| K062865 | SMALL VOLUME SYRINGE | Aug 23, 2007 | Substantially Equivalent |
| K000148 | RGP MULTI-PURPOSE SOLUTION ID 100136 | Apr 11, 2000 | Substantially Equivalent |
| K984573 | OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP | Sep 16, 1999 | Substantially Equivalent |
| K990480 | OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER | May 10, 1999 | Substantially Equivalent |
| K984575 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Jan 14, 1999 | Substantially Equivalent |
| K983973 | OPTI-ONE MULTI-PURPOSE SOLUTION | Dec 18, 1998 | Substantially Equivalent |
| K983780 | MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 | Dec 18, 1998 | Substantially Equivalent |
| K981561 | LIQUID ENZYME ID 90133 | Jul 24, 1998 | Substantially Equivalent |
| K981103 | TURBOSONICS LIMITED REUSE ULTRASONIC TIP | Jun 23, 1998 | Substantially Equivalent |