SITZMARKS
System, Gastrointestinal Motility (electrical)
LAFAYETTE PHARMACAL, INC.
The following data is part of a premarket notification filed by Lafayette Pharmacal, Inc. with the FDA for Sitzmarks.
Pre-market Notification Details
| Device ID | K881609 |
| 510k Number | K881609 |
| Device Name: | SITZMARKS |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | LAFAYETTE PHARMACAL, INC. 522 N. EARL AVE. Lafayette, IN 47903 |
| Contact | Robert A Sharp |
| Correspondent | Robert A Sharp LAFAYETTE PHARMACAL, INC. 522 N. EARL AVE. Lafayette, IN 47903 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-12 |
| Decision Date | 1988-07-08 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610858081306 | K881609 | 000 |
| 00610858081016 | K881609 | 000 |
| 00610858081023 | K881609 | 000 |
| 00610858081078 | K881609 | 000 |
| 00610858081085 | K881609 | 000 |
| 00610858081092 | K881609 | 000 |
| 00610858081108 | K881609 | 000 |
| 00610858081115 | K881609 | 000 |
| 00610858081122 | K881609 | 000 |
| 00610858081139 | K881609 | 000 |
| 00610858081009 | K881609 | 000 |
Trademark Results [SITZMARKS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SITZMARKS 73695673 1492888 Live/Registered |
LAFAYETTE PHARMACAL, INC. 1987-11-16 |
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