Submission Details
| 510(k) Number | K952558 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 02, 1995 |
| Decision Date | March 19, 1997 |
| Days to Decision | 656 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
Cleared
Traditional
AARON VAC 2
Mar 1997
Decision
656d
Days
Class 2
Risk
About This 510(k) Submission
K952558 is an FDA 510(k) clearance for the AARON VAC 2, a Instrument, Vitreous Aspiration And Cutting, Battery-powered (Class II — Special Controls, product code HKP), submitted by Aaron Medical Industries (St. Petersburg, US). The FDA issued a Cleared decision on March 19, 1997, 656 days after receiving the submission on June 2, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.
Device Classification
| Product Code | HKP — Instrument, Vitreous Aspiration And Cutting, Battery-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4150 |
Manufacturer
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