FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOSTON ADVANCE CLEANER
K Number: K974466
·
Decision Feb 19, 1998
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
32
Applicant Total
23
Review Days
85
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Basic Information
- Device Name
- BOSTON ADVANCE CLEANER
- K Number
- K974466
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5918
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Polymer Technology Corp.
- Date Received
- November 26, 1997
- Decision Date
- February 19, 1998
- 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 |
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Other Clearances by Polymer Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K011945 | RIGID GAS PERMEABLE CONTACT LENS SOLUTION | Sep 12, 2001 | Substantially Equivalent |
| K980133 | BAUSCH & LOMB WETTING AND SOAKING SOLUTION | Mar 11, 1998 | Substantially Equivalent |
| K973217 | BOSTON LIQUID ENZYMATIC CLEANER | Nov 24, 1997 | Substantially Equivalent |
| K970698 | BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS | May 6, 1997 | Substantially Equivalent |
| K951552 | BOSTON CONTACT LENS CASE | Jun 26, 1995 | Substantially Equivalent |
| K943177 | BOSTON(R) 7 - 30(ENFLUFOCON A) | Aug 25, 1994 | Substantially Equivalent |
| K942365 | BOSTON VII | Jun 23, 1994 | Substantially Equivalent |
| K923438 | BOSTON CONDITIONING SOLUTION | Dec 28, 1992 | Substantially Equivalent |
| K923587 | GLUCOSE TEST SYSTEM | Dec 28, 1992 | Substantially Equivalent |
| K923437 | BOSTON CLEANER II | Oct 28, 1992 | Substantially Equivalent |