K935299 is an FDA 510(k) clearance for the ASTROGLIDE. This device is classified as a Lubricant, Patient (Class I - General Controls, product code KMJ).
Submitted by Biofilm, Inc. (Vista, US). The FDA issued a Cleared decision on February 18, 1994, 108 days after receiving the submission on November 2, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6375.
| 510(k) Number | K935299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1993 |
| Decision Date | February 18, 1994 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KMJ - Lubricant, Patient |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6375 |