FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
O.R. TIP CLEANER
K Number: K903610
·
Decision Oct 19, 1990
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
6
Review Days
71
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Basic Information
- Device Name
- O.R. TIP CLEANER
- K Number
- K903610
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Inman Liebelt Corp.
- Date Received
- August 9, 1990
- Decision Date
- October 19, 1990
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Inman Liebelt Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K912211 | INTRAVASCULAR CATHETER SECURMENT DEVICE | Aug 9, 1991 | Substantially Equivalent |
| K912146 | URETERAL CATHETER HOLDER | Jul 26, 1991 | Substantially Equivalent |
| K905590 | UCEZ - STERILE LENS FOG REDUCTION DEVICE | May 10, 1991 | Substantially Equivalent |
| K905583 | ILC FORCEPS PADS | Apr 12, 1991 | Substantially Equivalent |
| K903611 | ILC LEG BAG HOLDER | Oct 26, 1990 | Substantially Equivalent |