The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Digital Thermometer Sheaths (oral And Rectal).
| Device ID | K882304 |
| 510k Number | K882304 |
| Device Name: | DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ABCO DEALERS, INC. 6601 W. MILL RD. P.O. BOX 23090 Milwaukee, WI 53218 -1238 |
| Contact | Molly Petr |
| Correspondent | Molly Petr ABCO DEALERS, INC. 6601 W. MILL RD. P.O. BOX 23090 Milwaukee, WI 53218 -1238 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-03 |
| Decision Date | 1988-07-12 |