The following data is part of a premarket notification filed by Huntington Laboratories, Inc. with the FDA for Sana-lube.
| Device ID | K853653 |
| 510k Number | K853653 |
| Device Name: | SANA-LUBE |
| Classification | Lubricant, Patient |
| Applicant | HUNTINGTON LABORATORIES, INC. 970 E. TIPTON Huntington, IN 46750 |
| Contact | Robert Macdonald |
| Correspondent | Robert Macdonald HUNTINGTON LABORATORIES, INC. 970 E. TIPTON Huntington, IN 46750 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-03 |
| Decision Date | 1985-11-13 |