FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AT EASE ADULT DIAPER
K Number: K880455
·
Decision Apr 14, 1988
Classifications
1
FEI Numbers
417
Registration Numbers
418
Same Product Code
55
Applicant Total
7
Review Days
72
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Basic Information
- Device Name
- AT EASE ADULT DIAPER
- K Number
- K880455
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5920
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Hospital Specialty Co.
- Date Received
- February 2, 1988
- Decision Date
- April 14, 1988
- Product Code
- EYQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EYQ | Garment, Protective, For Incontinence | FDA class 1 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EYQ), ordered by most recent decision date.
DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM
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DEODORIZING AND SOUND MUFFLING ANAL PAD
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LIB SYSTEM, BABY/ADULT DIAPER
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INTERA SHIELD AND INTERA UNDERGARMENT
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DRIPRIDE PROVIDE SLIM
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Other Clearances by Hospital Specialty Co.
| K Number | Device Name | ||
|---|---|---|---|
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | Apr 12, 1999 | Substantially Equivalent |
| K941099 | CLEAN-SORB | Sep 30, 1994 | Substantially Equivalent |
| K882094 | GARDS DEODORANT SANITARY NAPKIN | Sep 22, 1988 | Substantially Equivalent |
| K880454 | AT EASE STRESS PAD | Jun 16, 1988 | Substantially Equivalent |
| K822242 | SANITARY/OB NAPKINS | Sep 9, 1982 | Substantially Equivalent |
| K822433 | GARDS (UNSCENTED, MENSTRUAL PAD) | Aug 30, 1982 | Substantially Equivalent |