The following data is part of a premarket notification filed by Span-america Medical Systems, Inc. with the FDA for Lubricating Jelly, Low Viscosity.
| Device ID | K961502 |
| 510k Number | K961502 |
| Device Name: | LUBRICATING JELLY, LOW VISCOSITY |
| Classification | Lubricant, Patient |
| Applicant | SPAN-AMERICA MEDICAL SYSTEMS, INC. 70 COMMERCE DR. P.O. BOX 5231 Greenville, SC 29615 |
| Contact | Polly Thompson |
| Correspondent | Polly Thompson SPAN-AMERICA MEDICAL SYSTEMS, INC. 70 COMMERCE DR. P.O. BOX 5231 Greenville, SC 29615 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-19 |
| Decision Date | 1996-07-18 |
| Summary: | summary |