TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED)— 510(k) K051290
Substantially EquivalentProcter & Gamble Co.
FDA 510(k) clearance K051290 for TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, ULTRA ABSORBENCY (UNSCENTED AND SCENTED), Substantially Equivalent on 2005-12-27. Applicant: Procter & Gamble Co.. Device class: 2.
Clearance details
- Applicant
- Procter & Gamble Co.
- Product code
- Code HEB
- Device class
- Class 2
- Regulation
- 21 CFR 884.5470
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code HEB
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view all- K141018 — ORAL-B TEST DRIVE POWER BRUSH TRIAL PROGRAM KIT, ORAL-B TEST DRIVE POWER TOOTHBRUSH KIT, ORAL-B TEST DRIVE REFILL KIT
- K131543 — TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
- K091281 — TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA
- K091964 — CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS
- K081555 — TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
Adverse events under product code HEB
product code HEB- Injury
- 329
- Malfunction
- 5,647
- Total
- 5,976
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.