FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PH BUFFERING PLASTIC APPLICATOR TAMPON
K Number: K030474
·
Decision May 28, 2004
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
9
Review Days
471
Basic Information
- Device Name
- PH BUFFERING PLASTIC APPLICATOR TAMPON
- K Number
- K030474
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rostam , Ltd.
- Date Received
- February 12, 2003
- Decision Date
- May 28, 2004
- Product Code
- HEB
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HEB), ordered by most recent decision date.
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Other Clearances by Rostam , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K102445 | ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS | Nov 10, 2010 | Substantially Equivalent |
| K090071 | ROSTAM LTD. FRAGRANCED OR UNFRAGRANCED NEW PLASTIC APPLICATOR TAMPONS | May 28, 2009 | Substantially Equivalent |
| K062001 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | Dec 7, 2006 | Substantially Equivalent |
| K042773 | ROSTAM SCENTED AND UNSCENTED PLASTIC APPLICATOR TAMPONS | Nov 23, 2004 | Substantially Equivalent |
| K032080 | ROSTAM LTD FRAGRANCED PLASTIC APPLICATOR TAMPONS | Aug 14, 2003 | Substantially Equivalent |
| K020535 | INTERLUDE AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS | May 9, 2002 | Substantially Equivalent |
| K001641 | TAMPONS | Aug 3, 2000 | Substantially Equivalent |
| K965064 | ROSTAM APPLICATOR TAMPON/ROSTAM NON APPLICATOR TAMPON | Feb 20, 1997 | Substantially Equivalent |