The following data is part of a premarket notification filed by Bio-detek, Inc. with the FDA for Gp-100 Adult Electrosurgical Ground Pad/200 & 300.
| Device ID | K853291 |
| 510k Number | K853291 |
| Device Name: | GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 |
| Classification | Apparatus, Electrosurgical |
| Applicant | BIO-DETEK, INC. 171 FORBES BLVD. P.O. BOX 809 Mansfield, MA 02048 |
| Contact | Donald C Epstein |
| Correspondent | Donald C Epstein BIO-DETEK, INC. 171 FORBES BLVD. P.O. BOX 809 Mansfield, MA 02048 |
| Product Code | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-05 |
| Decision Date | 1985-10-10 |