Submission Details
| 510(k) Number | K942789 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 14, 1994 |
| Decision Date | August 12, 1994 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
Cleared
Traditional
MISTASSIST
Aug 1994
Decision
59d
Days
Class 1
Risk
About This 510(k) Submission
K942789 is an FDA 510(k) clearance for the MISTASSIST, a Applicator, Ent Drug (Class I — General Controls, product code LRD), submitted by The Merlin Corp. (Camarillo, US). The FDA issued a Cleared decision on August 12, 1994, 59 days after receiving the submission on June 14, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5220.
Device Classification
| Product Code | LRD — Applicator, Ent Drug |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 874.5220 |
Manufacturer
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