The following data is part of a premarket notification filed by Prism Enterprises, Inc. with the FDA for Mityvac.
Device ID | K011532 |
510k Number | K011532 |
Device Name: | MITYVAC |
Classification | Extractor, Vacuum, Fetal |
Applicant | PRISM ENTERPRISES, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 -5600 |
Contact | Howard M Holstein |
Correspondent | Howard M Holstein PRISM ENTERPRISES, INC. 555 THIRTEENTH ST. N.W. Washington, DC 20004 -5600 |
Product Code | HDB |
CFR Regulation Number | 884.4340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-18 |
Decision Date | 2001-07-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00888937003154 | K011532 | 000 |
00888937003116 | K011532 | 000 |
00888937003109 | K011532 | 000 |
30888937003032 | K011532 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MITYVAC 78206432 2908229 Live/Registered |
Lincoln Industrial Corporation 2003-01-23 |
MITYVAC 75021702 2060647 Live/Registered |
PRISM IP HOLDINGS LLC 1995-11-17 |
MITYVAC 72440047 1003947 Dead/Expired |
NEWARD ENTERPRISES, INC. 1972-11-02 |