FDA 510(k)
Substantially Equivalent
🇺🇸 United States
VENA * BRIDGE
K Number: K840403
·
Decision Mar 12, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
8
Review Days
41
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Basic Information
- Device Name
- VENA * BRIDGE
- K Number
- K840403
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Neward Enterprises, Inc.
- Date Received
- January 31, 1984
- Decision Date
- March 12, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- PM
- Third Party
- N
Other Clearances by Neward Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960549 | MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE | Aug 29, 1996 | Substantially Equivalent |
| K943938 | MITYVAC SUPER M STYLE VACUM EXTRACTOR, DISPOSABLE | May 3, 1995 | Substantially Equivalent |
| K934011 | MITYVAC(R) OBSTETRIC VAC DELIV KIT W/UNIV VAC RELEASE | May 4, 1994 | Substantially Equivalent |
| K925572 | MITYVAC DISPOS-A-PLATE DISPOSABLE LEG PLATE | Oct 8, 1993 | Substantially Equivalent |
| K913324 | MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT | Jun 22, 1992 | Substantially Equivalent |
| K910815 | CR SPIRAL ELECTRODE | Dec 10, 1991 | Substantially Equivalent |
| K890307 | MITYVAC M STYLE VACUUM EXTRACTOR, DISPOSABLE | Mar 31, 1989 | Substantially Equivalent |