FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUCTION TUBES: HOUSE, BARON
K Number: K930030
·
Decision Feb 25, 1994
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
76
Applicant Total
33
Review Days
416
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Basic Information
- Device Name
- SUCTION TUBES: HOUSE, BARON
- K Number
- K930030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4780
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thomasville Medical Assoc.
- Date Received
- January 5, 1993
- Decision Date
- February 25, 1994
- Product Code
- JCX
- 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 |
|---|---|---|---|
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Thomasville Medical Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K926429 | VAGINAL SPECULA: CUSCO, GUTTMAN, INFANT | Feb 28, 1994 | Substantially Equivalent |
| K926531 | HYSTERECTOMY FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926527 | ROTO FIT BIOPSY FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926535 | GOMCO CIRCUMCISION CLAMP | Feb 25, 1994 | Substantially Equivalent |
| K926533 | Z-CLAMP FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926540 | SOPHER AND BIERER OVUM FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926532 | ENDO CERVICAL CURETTE | Feb 25, 1994 | Substantially Equivalent |
| K926536 | DISPOSABLE PLASTIC VAGINAL SPECULA | Feb 25, 1994 | Substantially Equivalent |
| K926484 | CORSON MYOMA GRASPING FORCEPS | Feb 25, 1994 | Substantially Equivalent |
| K926471 | MOGAN CIRCUMCISION CLAMP | Feb 25, 1994 | Substantially Equivalent |