The following data is part of a premarket notification filed by Lukens Medical Corp. with the FDA for Lukens Pga, (polyglycolic Acid) Synthetic Absorbable Surgical Suture,coated, Braided-u.s.p..
| Device ID | K965162 |
| 510k Number | K965162 |
| Device Name: | LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P. |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | LUKENS MEDICAL CORP. THE LAHR CONSULTING GROUP,INC. ONE LETHBRIDGE PLAZA Mahwah, NJ 07430 |
| Contact | Brenda M Kelly |
| Correspondent | Brenda M Kelly LUKENS MEDICAL CORP. THE LAHR CONSULTING GROUP,INC. ONE LETHBRIDGE PLAZA Mahwah, NJ 07430 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-24 |
| Decision Date | 1997-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6620712443590 | K965162 | 000 |
| D66207124434209 | K965162 | 000 |
| D6620712443340 | K965162 | 000 |
| D6620712443180 | K965162 | 000 |