FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROMISE ABSORBENT PROTECTIVE PAD
K Number: K900421
·
Decision Jun 6, 1990
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
9
Review Days
127
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Basic Information
- Device Name
- PROMISE ABSORBENT PROTECTIVE PAD
- K Number
- K900421
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Scott Health Care
- Date Received
- January 30, 1990
- Decision Date
- June 6, 1990
- Product Code
- HHD
- 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 |
|---|---|---|---|
| HHD | Pad, Menstrual, Unscented | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHD), ordered by most recent decision date.
ALWAYS MENSTRUAL PADS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ALWAYS DUETS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
ENVIVE MINIFORMS
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
UNSCENTED INTERLABIAL MENSTRUAL PAD
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
GLADRAGS COTTON MENSTRUAL PAD
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
FLUSHIES FLUSHABLE/BIODEGRADABLE MENSTRUAL PADS/NAPKINS (ULTRA THINS)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by Scott Health Care
| K Number | Device Name | ||
|---|---|---|---|
| K954275 | MEPORE PLUS (9X15CM) | Dec 27, 1995 | Substantially Equivalent |
| K954274 | MEPORE (6X7) | Dec 19, 1995 | Substantially Equivalent |
| K945206 | ALLDRESS MULTI LAYERED WOUND DRESSING | Jan 12, 1995 | Substantially Equivalent |
| K932743 | MEFIX(R) ADHESIVE FABRIC FOR DRESSING FIXATION | Sep 10, 1993 | Substantially Equivalent |
| K905439 | HYPERGEL PROTECTIVE WOUND GEL | May 29, 1991 | Substantially Equivalent |
| K910857 | ALLDRESS MULTI LAYERED WOUND DRESSING | Apr 12, 1991 | Substantially Equivalent |
| K905438 | NORMLGEL PROTECTIVE WOUND GEL | Apr 1, 1991 | Substantially Equivalent |
| K897142 | MESALT STERILE DRESSING | Mar 27, 1990 | Substantially Equivalent |