The following data is part of a premarket notification filed by Implantech Associates Inc. with the FDA for Gluteal Implant, Models Rnd 5-x, Trd 6-x.
| Device ID | K052504 |
| 510k Number | K052504 |
| Device Name: | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X |
| Classification | Elastomer, Silicone Block |
| Applicant | IMPLANTECH ASSOCIATES INC. 6025 NICOLLE ST., SUITE B Ventura, CA 93003 |
| Contact | Stephen Meade |
| Correspondent | Stephen Meade IMPLANTECH ASSOCIATES INC. 6025 NICOLLE ST., SUITE B Ventura, CA 93003 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-13 |
| Decision Date | 2005-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M724SGRTSCM51 | K052504 | 000 |
| M724CCB571 | K052504 | 000 |
| M724CCB561 | K052504 | 000 |
| M724CCB551 | K052504 | 000 |
| M724CCB6SIZ2NS1 | K052504 | 000 |
| M724CCB5SIZNC2NS1 | K052504 | 000 |
| M724CCB5SIZK2NS1 | K052504 | 000 |
| M724CCB641 | K052504 | 000 |
| M724CCB6SIZ3NS1 | K052504 | 000 |
| M724CCB6SIZ1NS1 | K052504 | 000 |
| M724CCB5SIZ4NS1 | K052504 | 000 |
| M724CCB5SIZ3NS1 | K052504 | 000 |
| M724CCB5SIZ2NS1 | K052504 | 000 |
| M724CCB5SIZ1NS1 | K052504 | 000 |
| M724CCB5SIZ0NS1 | K052504 | 000 |
| M724CCB5SIZ6NS1 | K052504 | 000 |
| M724CCB5SIZ5NS1 | K052504 | 000 |
| M724CCB5K11 | K052504 | 000 |
| M724CCB5NC31 | K052504 | 000 |
| M724CCB631 | K052504 | 000 |
| M724SGRTSCM41 | K052504 | 000 |
| M724SGRTSCM31 | K052504 | 000 |
| M724SGRTSCM21 | K052504 | 000 |
| M724SGRTSCL21 | K052504 | 000 |
| M724SGRTSCL11 | K052504 | 000 |
| M724CCB621 | K052504 | 000 |
| M724CCB611 | K052504 | 000 |
| M724CCB5NC21 | K052504 | 000 |
| M724CCB5NC11 | K052504 | 000 |
| M724CCB5K21 | K052504 | 000 |
| M724CCB541 | K052504 | 000 |
| M724CCB531 | K052504 | 000 |
| M724CCB521 | K052504 | 000 |
| M724CCB511 | K052504 | 000 |
| M724CCB501 | K052504 | 000 |
| M724SGRTSCM11 | K052504 | 000 |
| M724CCB64SIZNS1 | K052504 | 000 |