Submission Details
| 510(k) Number | K020447 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 11, 2002 |
| Decision Date | April 12, 2002 |
| Days to Decision | 60 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Special
K020447 - MITYVAC MERLIN, MODEL 10027
(FDA 510(k) Clearance)
Apr 2002
Decision
60d
Days
Class 2
Risk
K020447 is an FDA 510(k) clearance for the MITYVAC MERLIN, MODEL 10027, a Extractor, Vacuum, Fetal (Class II — Special Controls, product code HDB), submitted by Prism Enterprises, Inc. (Washington, US). The FDA issued a Cleared decision on April 12, 2002, 60 days after receiving the submission on February 11, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4340.
Device Classification
| Product Code | HDB — Extractor, Vacuum, Fetal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4340 |
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