The following data is part of a premarket notification filed by J. Sklar Mfg. Co., Inc. with the FDA for Jacobs High Vacuum Suction Unit 05-2570.
| Device ID | K843693 |
| 510k Number | K843693 |
| Device Name: | JACOBS HIGH VACUUM SUCTION UNIT 05-2570 |
| Classification | Pump, Portable, Aspiration (manual Or Powered) |
| Applicant | J. SKLAR MFG. CO., INC. 38-04 WOODSIDE AVE. Long Island City, NY 11101 |
| Contact | Arnold E Gorman |
| Correspondent | Arnold E Gorman J. SKLAR MFG. CO., INC. 38-04 WOODSIDE AVE. Long Island City, NY 11101 |
| Product Code | BTA |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-19 |
| Decision Date | 1984-10-31 |