The following data is part of a premarket notification filed by Genesis Industries, Inc. with the FDA for Esp Four Well Tissue Culture Plate, Esp Six Well Tissue Culture Plate, Esp Micro Six Well Tissue Culture Plate, Esp Well.
| Device ID | K994361 |
| 510k Number | K994361 |
| Device Name: | ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL |
| Classification | Labware, Assisted Reproduction |
| Applicant | GENESIS INDUSTRIES, INC. 303 S. MCKAY AVE. P.O. BOX 39 Spring Valley, WI 54767 |
| Contact | Angela Richardson |
| Correspondent | Angela Richardson GENESIS INDUSTRIES, INC. 303 S. MCKAY AVE. P.O. BOX 39 Spring Valley, WI 54767 |
| Product Code | MQK |
| CFR Regulation Number | 884.6160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-27 |
| Decision Date | 2000-02-18 |
| Summary: | summary |