FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHEMOSITE IMPLANTABLE DRUG DELIVERY
K Number: K930632
·
Decision Dec 22, 1993
Classifications
1
FEI Numbers
79
Registration Numbers
79
Same Product Code
221
Applicant Total
6
Review Days
317
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Basic Information
- Device Name
- CHEMOSITE IMPLANTABLE DRUG DELIVERY
- K Number
- K930632
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5090
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Device Labs, Inc.
- Date Received
- February 8, 1993
- Decision Date
- December 22, 1993
- Product Code
- KMF
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KMF | Bandage, Liquid | FDA class 1 | General Hospital |
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Other Clearances by Device Labs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K904417 | CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM | Dec 5, 1990 | Substantially Equivalent |
| K902135 | PERCUTANEOUS INTRODUCER KIT | Aug 1, 1990 | Unknown |
| K901722 | CHEMOSITE(TM) IMPLANTABLE DRUG DELIVERY SYSTEM | Jul 3, 1990 | Substantially Equivalent |
| K883764 | INTRAVASCULAR ADMINISTRATION SET | Dec 19, 1988 | Substantially Equivalent |
| K882064 | LO-CORE NEEDLE | Jul 8, 1988 | Substantially Equivalent |