FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAFE & SOFT MAXI SHILEDS
K Number: K842837
·
Decision Oct 15, 1984
Classifications
1
FEI Numbers
307
Registration Numbers
307
Same Product Code
135
Applicant Total
23
Review Days
87
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SAFE & SOFT MAXI SHILEDS
- K Number
- K842837
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5435
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Ipco Corp.
- Date Received
- July 20, 1984
- Decision Date
- October 15, 1984
- 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 Ipco Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K871270 | PERFORM DENTURE BASE RESIN | May 29, 1987 | Substantially Equivalent |
| K850666 | STROBEX ULTRON ELECTROSURGE-DENTAL UNIT | May 29, 1985 | Substantially Equivalent |
| K850906 | TACTILE PLUS DENTAL ELEVATORS | Apr 12, 1985 | Substantially Equivalent |
| K842836 | SAFE & SOFT MINI PADS & MAXI PADS | Oct 15, 1984 | Substantially Equivalent |
| K842838 | SAFE & SOFT PANTY SHIELDS | Oct 5, 1984 | Substantially Equivalent |
| K841953 | ULTRA SHIELD BRIEFS | Jul 19, 1984 | Substantially Equivalent |
| K840753 | AMBEZE DISPOSABLE INCONTINENCE PANTS | Apr 13, 1984 | Substantially Equivalent |
| K840754 | MAXISHIELD INCONTINENCE CARE SYSTEM | Apr 13, 1984 | Substantially Equivalent |
| K840755 | MINIGARD DISPOSABLE LINERS | Apr 13, 1984 | Substantially Equivalent |
| K800293 | FILE, PULP CANAL | Feb 19, 1980 | Substantially Equivalent |