The following data is part of a premarket notification filed by Medi-source, Inc. with the FDA for Geohesive (tm), Model Numbers 1022l, 1023l, 1026l.
| Device ID | K903402 |
| 510k Number | K903402 |
| Device Name: | GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L |
| Classification | Electrode, Cutaneous |
| Applicant | MEDI-SOURCE, INC. 7719 STATE ROUTE 656 Sunbury, OH 43074 |
| Contact | Bruce Macfarlane |
| Correspondent | Bruce Macfarlane MEDI-SOURCE, INC. 7719 STATE ROUTE 656 Sunbury, OH 43074 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-08-22 |