Submission Details
| 510(k) Number | K831340 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 25, 1983 |
| Decision Date | June 08, 1983 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
Cleared
Traditional
DRAIN-R-DRAPE(EYE
Jun 1983
Decision
44d
Days
Class 2
Risk
About This 510(k) Submission
K831340 is an FDA 510(k) clearance for the DRAIN-R-DRAPE(EYE, a Drape, Patient, Ophthalmic (Class II — Special Controls, product code HMT), submitted by Sur-Tech, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983, 44 days after receiving the submission on April 25, 1983. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.
Device Classification
| Product Code | HMT — Drape, Patient, Ophthalmic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4370 |
Manufacturer
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