Submission Details
| 510(k) Number | K021012 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 29, 2002 |
| Decision Date | June 25, 2002 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM
Jun 2002
Decision
88d
Days
Class 2
Risk
About This 510(k) Submission
K021012 is an FDA 510(k) clearance for the LAMINARIA 2MM/3MM/4MM/5MM/6MM/7MM/8MM/9MM, a Dilator, Cervical, Hygroscopic-laminaria (Class II — Special Controls, product code HDY), submitted by Quality Medical Solusions, LLC (Alpharetta, US). The FDA issued a Cleared decision on June 25, 2002, 88 days after receiving the submission on March 29, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4260.
Device Classification
| Product Code | HDY — Dilator, Cervical, Hygroscopic-laminaria |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4260 |
Manufacturer
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