The following data is part of a premarket notification filed by Laparomed Corp. with the FDA for Laparomed Ligating Loop.
| Device ID | K921053 |
| 510k Number | K921053 |
| Device Name: | LAPAROMED LIGATING LOOP |
| Classification | Applicator, Ent |
| Applicant | LAPAROMED CORP. 9272 JERONIMO RD., UNIT 109 Irvine, CA 92718 |
| Contact | Paul Lubock |
| Correspondent | Paul Lubock LAPAROMED CORP. 9272 JERONIMO RD., UNIT 109 Irvine, CA 92718 |
| Product Code | KCJ |
| CFR Regulation Number | 874.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-05 |
| Decision Date | 1992-08-06 |