The following data is part of a premarket notification filed by Shippert Medical Technologies Corp. with the FDA for Expandacell Anti-fog Instrument Wipe (with Alcohol)/(without).
Device ID | K964334 |
510k Number | K964334 |
Device Name: | EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) |
Classification | Laparoscope, General & Plastic Surgery |
Applicant | SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
Contact | Sarah Maxwell Lake |
Correspondent | Sarah Maxwell Lake SHIPPERT MEDICAL TECHNOLOGIES CORP. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
Product Code | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-31 |
Decision Date | 1996-12-09 |
Summary: | summary |