The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt Model 1110-5 Pmt Peritoneal Catheter.
Device ID | K884036 |
510k Number | K884036 |
Device Name: | PMT MODEL 1110-5 PMT PERITONEAL CATHETER |
Classification | Shunt, Central Nervous System And Components |
Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Contact | Alfred A Iversen |
Correspondent | Alfred A Iversen PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
Product Code | JXG |
CFR Regulation Number | 882.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-26 |
Decision Date | 1988-12-22 |