Submission Details
| 510(k) Number | K061013 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 13, 2006 |
| Decision Date | August 15, 2006 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
PLAYTEX EMBRACE PETITE BREAST PUMP
Aug 2006
Decision
124d
Days
Class 2
Risk
About This 510(k) Submission
K061013 is an FDA 510(k) clearance for the PLAYTEX EMBRACE PETITE BREAST PUMP, a Pump, Breast, Powered (Class II — Special Controls, product code HGX), submitted by Playtex Products, Inc. (Allendale, US). The FDA issued a Cleared decision on August 15, 2006, 124 days after receiving the submission on April 13, 2006. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5160.
Device Classification
| Product Code | HGX — Pump, Breast, Powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5160 |
Manufacturer
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