The following data is part of a premarket notification filed by Span-america Medical Systems, Inc. with the FDA for Modified American Lubricating Jelly, 2.7 & 5.0.
| Device ID | K882506 |
| 510k Number | K882506 |
| Device Name: | MODIFIED AMERICAN LUBRICATING JELLY, 2.7 & 5.0 |
| Classification | Lubricant, Patient |
| Applicant | SPAN-AMERICA MEDICAL SYSTEMS, INC. P.O. BOX 5231 Greenville, SC 29606 |
| Contact | Charles B Mitchell |
| Correspondent | Charles B Mitchell SPAN-AMERICA MEDICAL SYSTEMS, INC. P.O. BOX 5231 Greenville, SC 29606 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-09 |
| Decision Date | 1988-09-09 |