The following data is part of a premarket notification filed by Shippert Medical Technologies Corp. with the FDA for Expandacell Instrument Wipe.
| Device ID | K960621 |
| 510k Number | K960621 |
| Device Name: | EXPANDACELL INSTRUMENT WIPE |
| Classification | Gauze, External (with Drug/biologic/animal Source Material) |
| 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 | GER |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-13 |
| Decision Date | 1996-04-01 |
| Summary: | summary |