FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYLASHIELD CL
K Number: K994170
·
Decision Mar 2, 2000
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
32
Applicant Total
2
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HYLASHIELD CL
- K Number
- K994170
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5918
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomatrix, Inc.
- Date Received
- December 10, 1999
- Decision Date
- March 2, 2000
- Product Code
- MRC
- 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 |
|---|---|---|---|
| MRC | Products, Contact Lens Care, Rigid Gas Permeable | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRC), ordered by most recent decision date.
cleadew GP hydra one
FDA 510(k)
FDA Class 2
·Ophthalmic
Boston One Step Liquid Enzymatic Cleaner
FDA 510(k)
FDA Class 2
·Ophthalmic
VibrantVue Scleral Saline
FDA 510(k)
FDA Class 2
·Ophthalmic
MaxiTears Contacts PF
FDA 510(k)
FDA Class 2
·Ophthalmic
Nutrifill
FDA 510(k)
FDA Class 2
·Ophthalmic
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Biomatrix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993362 | HYLASINE | Mar 13, 2000 | Substantially Equivalent |