Submission Details
| 510(k) Number | K970698 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 25, 1997 |
| Decision Date | May 06, 1997 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
K970698 - BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
(FDA 510(k) Clearance)
May 1997
Decision
70d
Days
Class 2
Risk
K970698 is an FDA 510(k) clearance for the BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Polymer Technology Corp. (Rochester, US). The FDA issued a Cleared decision on May 6, 1997, 70 days after receiving the submission on February 25, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.
Device Classification
| Product Code | HQD — Lens, Contact (other Material) - Daily |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5916 |
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