Submission Details
| 510(k) Number | K031015 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 31, 2003 |
| Decision Date | June 23, 2003 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
EMBRYOGLUE
Jun 2003
Decision
84d
Days
Class 2
Risk
About This 510(k) Submission
K031015 is an FDA 510(k) clearance for the EMBRYOGLUE, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Vitrolife Sweden AB (Gothenberg, SE). The FDA issued a Cleared decision on June 23, 2003, 84 days after receiving the submission on March 31, 2003. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.
Device Classification
| Product Code | MQL — Media, Reproductive |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6180 |
Manufacturer
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