The following data is part of a premarket notification filed by Parker Laboratories, Inc. with the FDA for Aqualube(tm).
| Device ID | K864556 |
| 510k Number | K864556 |
| Device Name: | AQUALUBE(TM) |
| Classification | Lubricant, Patient |
| Applicant | PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange, NJ 07050 |
| Contact | Martin Buchalter |
| Correspondent | Martin Buchalter PARKER LABORATORIES, INC. 307 WASHINGTON ST. Orange, NJ 07050 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-19 |
| Decision Date | 1986-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855683006371 | K864556 | 000 |
| 30855683006365 | K864556 | 000 |
| 20855683006474 | K864556 | 000 |
| 10855683006736 | K864556 | 000 |