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FDA 510(k)

MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS

K-Number: K070745 · 2007-04-13

ApplicantPlaytex Products, Inc.
Decision Date2007-04-13
Product CodeHIL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS is the device name listed in this FDA 510(k) record. The listed applicant is Playtex Products, Inc.. It received FDA 510(k) clearance on 2007-04-13 under 510(k) number K070745. The device is classified under product code HIL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS?

MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS is a medical device that received FDA 510(k) clearance on 2007-04-13. The listed applicant is Playtex Products, Inc.. The 510(k) number is K070745.

When did MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS receive FDA 510(k) clearance?

MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS received FDA 510(k) clearance on 2007-04-13, under 510(k) number K070745.

Who is the listed applicant for MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS?

The FDA 510(k) record lists Playtex Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS?

The FDA product code for MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS is HIL.

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Other records listing Playtex Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K073662PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONSK072376PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONSK061013PLAYTEX EMBRACE PETITE BREAST PUMPK060981PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONSK032636PLAYTEX UNSCENTED CARDBOARD APPLICATOR TAMPON #13203 (COLORED) AND # 13203 PV (NON-COLORED)K022594PLAYTEX BREAST PUMP

View all 17 devices →

Related Devices (Code: HIL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132819PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONSPlaytex Manufacturing, Inc.K120245PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONSPlaytex, Inc.K111684PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELDPlaytex Manufacturing, Inc.K081555TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTEDProcter & Gamble Co.K073662PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONSPlaytex Products, Inc.K072376PLAYTEX GENTLE GLIDE, PLAYTEX GENTLE GLIDE MULTIPACK TAMPONSPlaytex Products, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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