The following data is part of a premarket notification filed by M.p. Video, Inc. with the FDA for Medicam Endocoupler And Beamsplitter.
Device ID | K941693 |
510k Number | K941693 |
Device Name: | MEDICAM ENDOCOUPLER AND BEAMSPLITTER |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | M.P. VIDEO, INC. 4 MARC RD. Medway, MA 02053 |
Contact | Winifred Shannon |
Correspondent | Winifred Shannon M.P. VIDEO, INC. 4 MARC RD. Medway, MA 02053 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-06 |
Decision Date | 1994-06-27 |