FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950
K Number: K990371
·
Decision Apr 21, 1999
Classifications
1
FEI Numbers
440
Registration Numbers
440
Same Product Code
687
Applicant Total
6
Review Days
72
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Basic Information
- Device Name
- DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950
- K Number
- K990371
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5570
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Post Medical, Inc.
- Date Received
- February 8, 1999
- Decision Date
- April 21, 1999
- Product Code
- FMI
- 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 |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | FDA class 2 | General Hospital |
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Other Clearances by Post Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972536 | SYRINGE NEEDLE REMOVER (S.N.R.) | Aug 15, 1997 | Substantially Equivalent |
| K925086 | AUTOMATIC NEEDLE DISCONECT (A.N.D.) | May 9, 1994 | Substantially Equivalent |
| K925816 | SHARPS CONTAINMENT SYSTEM | Apr 29, 1994 | Substantially Equivalent |
| K830946 | MALE EXTERNAL CATHETER | Apr 28, 1983 | Substantially Equivalent |
| K830947 | SYRINGE/NEEDLE DISPOS-BOX-CUTTER/CRIMPER | Apr 12, 1983 | Substantially Equivalent |