Submission Details
| 510(k) Number | K070745 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 19, 2007 |
| Decision Date | April 13, 2007 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Special
K070745: MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS
Apr 2007
Decision
25d
Days
Class 2
Risk
About This 510(k) Submission
K070745 is an FDA 510(k) clearance for the MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Playtex Products, Inc. (Dover, US). The FDA issued a Cleared decision on April 13, 2007, 25 days after receiving the submission on March 19, 2007. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.
Device Classification
| Product Code | HIL — Tampon, Menstrual, Scented, Scented-deodorized |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.5460 |
| Definition | A Scented Or Scented-deodorized Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge. |
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