FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BONN MICRO IRIS HOOK (NON-STERILE) #7613
K Number: K801469
·
Decision Jul 28, 1980
Classifications
1
FEI Numbers
187
Registration Numbers
187
Same Product Code
9
Applicant Total
140
Review Days
34
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Basic Information
- Device Name
- BONN MICRO IRIS HOOK (NON-STERILE) #7613
- K Number
- K801469
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Edward Weck, Inc.
- Date Received
- June 24, 1980
- Decision Date
- July 28, 1980
- Product Code
- HNQ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HNQ | Hook, Ophthalmic | FDA class 1 | Ophthalmic |
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|---|---|---|---|
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| K914470 | PNEUMO-SEAL(TM) | Nov 29, 1991 | Substantially Equivalent |
| 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 |
| K897045 | BOWIE-DICK TEST CARD CATALOG NUMBER 008018 | Feb 15, 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 |