510(k) K820325
- Device
- STERICIDAL
- Applicant
- BREGER MUELLER WEST
- 510(k) number
- K820325
- Product code
- HPX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-04-21
- Date received
- 1982-02-08
- Regulation
- 510(k) Premarket Notification
- Classification name
- Lens, Contact (polymethylmethacrylate)
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ophthalmic
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers
- 3012228452
- 3013398957
- 1065845
- 9612500
- 1123818
- 1313525
- 1281950
- 1835957
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HPX
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K955777 | PMMA CLASIC | Rand Scientific Corp. | 1996-05-16 |
| K940106 | KERATOPLASTY SUTURING LENS | Visionary Technologies of Miami, Inc. | 1994-05-25 |
| K913081 | MULTI-VIEW BIFOCALS | Camp Contact Lenses | 1991-10-23 |
| K897021 | MARTIN-HENSLEY SEGMENT LENS | Bruce W. Martin O.D. and Edward Hensley | 1990-06-22 |
| K895411 | OPTIKEM PMMA CONTACT LENS | Optikem Polymers, Inc. | 1990-02-27 |
| K874591 | ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY | Vitreo Dynamics, Co. | 1988-05-03 |
| K865111 | CHARTER HARD CONTACT LENS CLEANING SOLUTION | Paco Pharmaceutical Services, Inc. | 1987-01-20 |
| K864343 | BL1 (HARD CONTACT LENS) | Beta Labs, Inc. | 1986-11-28 |
| K863974 | CHARTER LABORATORIES INC. LENS LUBRICANT | Paco Pharmaceutical Services, Inc. | 1986-11-10 |
| K862952 | CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES | Paco Pharmaceutical Services, Inc. | 1986-09-25 |
| K862811 | AQUALUX LENS CASE | Safeway Products, Inc. | 1986-09-03 |
| K861643 | STYLEKEEPER CONTACT LENS CARRYING CASE | Allergan, Inc. | 1986-06-02 |
| K860677 | EASY EYES TM LENS CARRYING CASE | Applied Laboratories, Inc. | 1986-05-29 |
| K861642 | LENSKEEPER CONTACT LENS CARRYING CASE | Allergan, Inc. | 1986-05-29 |
| K861712 | WETTING & SOAKING HARD CONTACT LENS SOLUTION | Maurry Biological Co. | 1986-05-29 |
Legacy Summary
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FDA Review
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