FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOWIE-DICK TEST CARD CATALOG NUMBER 008018
K Number: K897045
·
Decision Feb 15, 1990
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
264
Applicant Total
140
Review Days
58
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Basic Information
- Device Name
- BOWIE-DICK TEST CARD CATALOG NUMBER 008018
- K Number
- K897045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2800
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Edward Weck, Inc.
- Date Received
- December 19, 1989
- Decision Date
- February 15, 1990
- Product Code
- JOJ
- 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 |
|---|---|---|---|
| JOJ | Indicator, Physical/Chemical Sterilization Process | FDA class 2 | General Hospital |
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|---|---|---|---|
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| K911272 | ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 | Jul 2, 1991 | Substantially Equivalent |
| K902108 | HEM-O-LOK(TM) | Aug 6, 1990 | Substantially Equivalent |
| K902232 | WECK ELECTROSURGICAL GENERATOR #174200 | Aug 2, 1990 | Substantially Equivalent |
| K871110 | CORONARY ARTERY BYPASS GRAFT (CABG) MARKER | Aug 27, 1987 | Substantially Equivalent |
| K851251 | AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 | Jul 2, 1985 | Substantially Equivalent |
| K851258 | WECK LX TM SKIN STAPLER | Jun 7, 1985 | Substantially Equivalent |