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 |