The following data is part of a premarket notification filed by Martland Healthcare, Inc. with the FDA for Neuray Surgical Patties And Strips.
Device ID | K923027 |
510k Number | K923027 |
Device Name: | NEURAY SURGICAL PATTIES AND STRIPS |
Classification | Neurosurgical Paddie |
Applicant | MARTLAND HEALTHCARE, INC. 1068 RT. 85 Waterford, CT 06385 |
Contact | Jon C Martinsen |
Correspondent | Jon C Martinsen MARTLAND HEALTHCARE, INC. 1068 RT. 85 Waterford, CT 06385 |
Product Code | HBA |
CFR Regulation Number | 882.4700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-23 |
Decision Date | 1992-08-28 |