FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BOUNDARY HEADWEAR
K Number: K831357
·
Decision Jun 2, 1983
Classifications
1
FEI Numbers
291
Registration Numbers
291
Same Product Code
31
Applicant Total
72
Review Days
37
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
- BOUNDARY HEADWEAR
- K Number
- K831357
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Procter & Gamble Mfg. Co.
- Date Received
- April 26, 1983
- Decision Date
- June 2, 1983
- Product Code
- FYF
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FYF | Cap, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYF), ordered by most recent decision date.
SHOE COVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIOMED SURGICAL CAPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL CAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIOMED SURGICAL HOOD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIOMED BOUFFANT CAPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGEON'S CAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |