The following data is part of a premarket notification filed by Arc Medical Supplies (beijing) Co, Ltd. with the FDA for Pga (polyglycolic) Synthetic Absorbable Suture U.s.p..
| Device ID | K022664 |
| 510k Number | K022664 |
| Device Name: | PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. 1591 S. MOORLAND RD. SUITE 104 New Berlin, WI 53151 |
| Contact | Charles F Andrews |
| Correspondent | Charles F Andrews ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. 1591 S. MOORLAND RD. SUITE 104 New Berlin, WI 53151 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-09 |
| Decision Date | 2002-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20814639022753 | K022664 | 000 |
| 40814639022733 | K022664 | 000 |
| 20814639022722 | K022664 | 000 |
| 20814639024955 | K022664 | 000 |
| 20814639024948 | K022664 | 000 |
| 10814639025511 | K022664 | 000 |
| 10814639026037 | K022664 | 000 |