FDA 510(k)
Substantially Equivalent
🇺🇸 United States
BOUNDARY REINFORCED SINGLE-USE GOWNS
K Number: K834339
·
Decision Mar 5, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
72
Review Days
84
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Basic Information
- Device Name
- BOUNDARY REINFORCED SINGLE-USE GOWNS
- K Number
- K834339
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Procter & Gamble Mfg. Co.
- Date Received
- December 12, 1983
- Decision Date
- March 5, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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 |
| K861863 | MODIFIED PROTECTIVE GARMENT | Aug 11, 1986 | 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 |