FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INSTRUMENTS NONSTERILE & STERILE
K Number: K802726
·
Decision Nov 19, 1980
Classifications
1
FEI Numbers
211
Registration Numbers
211
Same Product Code
33
Applicant Total
9
Review Days
23
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Basic Information
- Device Name
- INSTRUMENTS NONSTERILE & STERILE
- K Number
- K802726
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4535
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Ascep, Inc.
- Date Received
- October 27, 1980
- Decision Date
- November 19, 1980
- Product Code
- HAO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| HAO | Instrument, Surgical, Non-Powered | FDA class 1 | Neurology |
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Other Clearances by Ascep, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830219 | VARIOUS INSTRUMENTS & INSTRUMENT TRAYS | Apr 12, 1983 | Substantially Equivalent |
| K822893 | G.E.V. DISPOSABLE SCALPELS | Oct 22, 1982 | Substantially Equivalent |
| K810004 | STERILE DISPOSABLE INSTRUMENT TRAYS | Jan 26, 1981 | Substantially Equivalent |
| K791886 | I.V. CARE KIT | Oct 26, 1979 | Substantially Equivalent |
| K791885 | I.V. START SET | Oct 22, 1979 | Substantially Equivalent |
| K791887 | CENTRAL VENOUS CATHETER DRESSING TRAY | Oct 17, 1979 | Substantially Equivalent |
| K791888 | CATHETER CARE KIT REORDER 7940&7941 | Oct 17, 1979 | Substantially Equivalent |
| K791889 | SUTURE REMOVAL TRAY, REORDER 7950&7951 | Oct 17, 1979 | Substantially Equivalent |