FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFIED PROTECTIVE GARMENT
K Number: K861863
·
Decision Aug 11, 1986
Classifications
1
FEI Numbers
417
Registration Numbers
418
Same Product Code
55
Applicant Total
72
Review Days
88
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Basic Information
- Device Name
- MODIFIED PROTECTIVE GARMENT
- K Number
- K861863
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.5920
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Procter & Gamble Mfg. Co.
- Date Received
- May 15, 1986
- Decision Date
- August 11, 1986
- 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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DRIPRIDE PROVIDE SLIM
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Other Clearances by Procter & Gamble Mfg. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K873457 | SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS | Jan 19, 1988 | Substantially Equivalent |
| K873036 | ATTENDS INCONTINENT BRIEF | Jan 19, 1988 | Substantially Equivalent |
| K864673 | UNSCENTED MENSTRUAL PAD | Jan 21, 1987 | Substantially Equivalent |
| K862348 | SINGLE-USE PATIENT UNDERPAD | Jul 2, 1986 | Substantially Equivalent |
| K860598 | MODIFIED PROTECTIVE GARMENT FOR INCONTINENTS | Mar 5, 1986 | Substantially Equivalent |
| K853880 | ATTENDS DISPOS. UNDERPAD | Oct 16, 1985 | Substantially Equivalent |
| K853000 | SCENTED ALWAYS PANTILINERS | Sep 6, 1985 | Substantially Equivalent |
| K852985 | UNSCENTED ALWAYS PANTILINERS | Aug 29, 1985 | Substantially Equivalent |
| K850956 | ALWAYS MAXIPADS - SCENTED | May 14, 1985 | Substantially Equivalent |
| K850939 | ALWAYS SUPER MAXIPAD-SCENTED | May 14, 1985 | Substantially Equivalent |