The following data is part of a premarket notification filed by Tetra Group U.s.a., Inc. with the FDA for Tetra Natal-mat Water Flotation Mat..
| Device ID | K802833 |
| 510k Number | K802833 |
| Device Name: | TETRA NATAL-MAT WATER FLOTATION MAT. |
| Classification | Mattress, Flotation Therapy, Non-powered |
| Applicant | TETRA GROUP U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IKY |
| CFR Regulation Number | 880.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-12 |
| Decision Date | 1980-12-10 |