FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MUCOUS SPECIMEN TRAP
K Number: K913643
·
Decision Oct 10, 1991
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
8
Applicant Total
30
Review Days
57
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Basic Information
- Device Name
- MUCOUS SPECIMEN TRAP
- K Number
- K913643
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Device Inspection Co., Inc.
- Date Received
- August 14, 1991
- Decision Date
- October 10, 1991
- Product Code
- BYZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| BYZ | Trap, Sterile Specimen | FDA class 2 | General Hospital |
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Other Clearances by Medical Device Inspection Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945826 | J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS | Aug 4, 1995 | Substantially Equivalent |
| K932072 | JARIT SURGICAL INSTRUMENTS | Jan 11, 1994 | Substantially Equivalent |
| K931594 | THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM | Dec 21, 1993 | Substantially Equivalent |
| K933580 | POWER WORK TABLE | Nov 5, 1993 | Substantially Equivalent |
| K933581 | POWERMATIC TREATMENT TABLE | Nov 5, 1993 | Substantially Equivalent |
| K933578 | POWERMATIC MAT PLATFORM | Nov 5, 1993 | Substantially Equivalent |
| K933577 | POWERMATIC EXAMINATION TABLE | Sep 30, 1993 | Substantially Equivalent |
| K922045 | SHOWER CHAIRS | May 26, 1992 | Substantially Equivalent |
| K912075 | C-SECTION TRAY | Apr 7, 1992 | Unknown |
| K914174 | STERILE DISPOSABLE WET SKIN SCRUB TRAY | Feb 24, 1992 | Unknown |