FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL CAPS
K Number: K874066
·
Decision Nov 4, 1987
Classifications
1
FEI Numbers
291
Registration Numbers
291
Same Product Code
31
Applicant Total
11
Review Days
30
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Basic Information
- Device Name
- SURGICAL CAPS
- K Number
- K874066
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Interpro Intl., Inc.
- Date Received
- October 5, 1987
- Decision Date
- November 4, 1987
- 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.
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NIOMED SURGICAL CAPS
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NIOMED SURGICAL HOOD
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NIOMED BOUFFANT CAPS
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SURGEON'S CAP
FDA 510(k)
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Other Clearances by Interpro Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890968 | VINYL EXAMINATION GLOVES (MFG. SALZGITTER MOREX) | Jul 31, 1989 | Substantially Equivalent |
| K890891 | LATEX EXAMINATION GLOVES (MFG. NINGBO MEDICAL) | Jul 14, 1989 | Substantially Equivalent |
| K891642 | PATIENT EXAMINATION GLOVES (LATEX) | Jul 14, 1989 | Substantially Equivalent |
| K891438 | PATIENT EXAMINATION GLOVES (LATEX) | May 31, 1989 | Substantially Equivalent |
| K891440 | PATIENT EXAMINATION GLOVES (LATEX) | May 31, 1989 | Substantially Equivalent |
| K881374 | SURGEONS GLOVES | Aug 5, 1988 | Substantially Equivalent |
| K874067 | GUAZE SPONGES | Dec 14, 1987 | Substantially Equivalent |
| K874766 | INTERPRO INT'L, INC. ISOLATION GOWN | Dec 10, 1987 | Substantially Equivalent |
| K874064 | SHOE COVERS | Nov 4, 1987 | Substantially Equivalent |
| K874065 | LAPAROTOMY SPONGES | Nov 4, 1987 | Substantially Equivalent |