Submission Details
| 510(k) Number | K942365 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 17, 1994 |
| Decision Date | June 23, 1994 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
Cleared
Traditional
BOSTON VII
Jun 1994
Decision
37d
Days
Class 2
Risk
About This 510(k) Submission
K942365 is an FDA 510(k) clearance for the BOSTON VII, 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 June 23, 1994, 37 days after receiving the submission on May 17, 1994. 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 |
Manufacturer
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