FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDCO MEMORY RETRACTOR SYSTEM
K Number: K874829
·
Decision Mar 24, 1988
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
42
Applicant Total
7
Review Days
121
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Basic Information
- Device Name
- MEDCO MEMORY RETRACTOR SYSTEM
- K Number
- K874829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4800
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Medical Equipment Development Co., Inc.
- Date Received
- November 24, 1987
- Decision Date
- March 24, 1988
- Product Code
- GZT
- 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 |
|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | FDA class 2 | Neurology |
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Other Clearances by Medical Equipment Development Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911973 | LINEAR ACCELERATOR COLLIMATOR | Oct 15, 1992 | Substantially Equivalent |
| K901670 | GNOMOS STEREOTACTIC DEVICE | Jul 3, 1990 | Substantially Equivalent |
| K895537 | MODIFIED MEMORY RETRACTOR ARM | Sep 22, 1989 | Substantially Equivalent |
| K893911 | MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM | Aug 29, 1989 | Substantially Equivalent |
| K874833 | ARC ADAPTER ASSEMBLY | Mar 3, 1988 | Substantially Equivalent |
| K802399 | MODEL 2500 PNEUMATIC PERCUSSOR | Oct 23, 1980 | Substantially Equivalent |